The Hazard Analysis was not properly completed - FDA stated, the company did "not clearly indicate whether you determined that a hazard you have identified and evaluated requires a preventive control (except at limited steps where you have identified a CCP). You include an evaluation of identified potential hazards to assess “likelihood/severity” and their specific “risk” (e.g., “low risk,” “high risk”), but your forms do not specifically indicate whether you have determined that a hazard requires a preventive control. Your hazard analysis worksheets, under the column header “Specific control measure to eliminate or acceptably reduce the hazard,” list measures that you call “Pre-Requisite Programs.”....some of the prerequisite programs listed are verification activities rather than preventive control measures for specific hazards (e.g., COA verification, test ingredient). "
The HA "did not clearly indicate whether you determined that pathogens such as Salmonella in your tahini ingredient are a hazard requiring a preventive control. Your facility manufactures various RTE hummus products using ingredients such as tahini that are considered RTE and do not undergo further processing in your facility to significantly minimize pathogens prior to inclusion into your finished product." "Tahini has a known history of contamination with Salmonella, and you should have identified it as a hazard that requires a preventive control, i.e., a supply-chain control, as required by 21 CFR 117.405(a)(1) for a hazard that is controlled by a supplier. It is not clear whether your evaluation of the hazards at the tahini receiving step determined the need for required preventive controls."
The company "did not identify and evaluate whether environmental pathogens are a hazard requiring a preventive control, in accordance with 21 CFR 117.130(c)(ii). You manufacture RTE food products (multiple varieties of hummus) that are exposed to the environment at filling where the food could be contaminated with environmental pathogens, such as L. monocytogenes or Salmonella, and the food does not receive a treatment or otherwise include a control measure (such as a formulation lethal to the pathogen) that would significantly minimize the pathogen."
Other issues included issues with verification and verification actions associated with the environmental monitoring program and some GMP items.
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/sabra-dipping-company-llc-615938-12012021
Sabra Dipping Company, LLC
MARCS-CMS 615938 — DECEMBER 01, 2021
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/sabra-dipping-company-llc-615938-12012021
Sabra Dipping Company, LLC
MARCS-CMS 615938 — DECEMBER 01, 2021
Recipient:
Mr. Joey Bergstein
President & CEO
Sabra Dipping Company, LLC
777 Westchester Avenue, Third Floor
White Plains, NY 10604-3520
United States
Issuing Office:
Division of Human and Animal Food Operations East II
United States
WARNING LETTER
CMS #615938
December 1, 2021
Dear Mr. Bergstein:
The United States Food and Drug Administration (FDA) and Virginia Department of Agriculture and Consumer Services (VDACS) jointly inspected your ready-to-eat (RTE) hummus manufacturing facility located at 15900 Sabra Way, South Chesterfield, Virginia, from April 28, 2021 through May 6, 2021. The inspection was initiated by FDA and VDACS after FDA Investigators collected a sample of Sabra Classic Hummus from retail and subsequent testing revealed the sample contained Salmonella enterica serovar Havana Group G (hereinafter Salmonella Havana). After being notified by FDA on March 26, 2021, you initiated a Class I voluntary recall of your Sabra Classic Hummus product.
During a joint inspection of your facility, FDA and VDACS Investigators found serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (CGMP & PC rule), Title 21, Code of Federal Regulations, Part 117 (21 CFR Part 117). At the conclusion of the inspection, the Investigators issued you an FDA Form 483, Inspectional Observations. Based on FDA’s inspectional findings, we have determined that the RTE hummus products manufactured in your facility are adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 342(a)(4)], in that they were prepared, packed or held under insanitary conditions whereby they may have been contaminated with filth or rendered injurious to health. In addition, failure of the owner, operator, or agent in charge of a covered facility to comply with the preventive controls provisions of the CGMP & PC rule (located in subparts A, C, D, E, F, and G of part 117) is prohibited by section 301(uu) of the Act [21 U.S.C. § 331(uu)].
Additionally, the presence of Salmonella Havana in your RTE hummus products, as evidenced by the laboratory analysis of FDA’s retail sampling, causes your recalled Classic hummus products to be adulterated within the meaning of section 402(a)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 342(a)(1)] in that they bear or contain an added poisonous or deleterious substance which may render them injurious to health. You may find the Act and further information about the CGMP & PC rule through links in FDA’s home page at www.fda.gov.External Link Disclaimer
We received your written responses on May 27, 2021 and July 8, 2021, which describe your completed and planned corrective actions. After reviewing the inspectional findings and responses you provided, we are issuing this letter to advise you of FDA’s concerns and provide detailed information describing the findings at your facility.
Hazard Analysis and Risk-Based Preventive Controls (21 CFR Part 117, Subpart C)
1. Your hazard analysis did not appropriately identify and evaluate known or reasonably foreseeable hazards to determine whether they require a preventive control, as required by 21 CFR 117.130(a)(1).
Your hazard analyses “Hummus Ingredient – Hazard Analysis Worksheet” dated April 26, 2021 (Version #07) and “Hummus Process – Hazard Analysis Worksheet” dated March 19, 2021 (Version #07) do not clearly indicate whether you determined that a hazard you have identified and evaluated requires a preventive control (except at limited steps where you have identified a CCP). You include an evaluation of identified potential hazards to assess “likelihood/severity” and their specific “risk” (e.g., “low risk,” “high risk”), but your forms do not specifically indicate whether you have determined that a hazard requires a preventive control. Your hazard analysis worksheets, under the column header “Specific control measure to eliminate or acceptably reduce the hazard,” list measures that you call “Pre-Requisite Programs.” The terminology in this column header is consistent with the definition of “preventive controls” in 21 CFR 117.3. In reviewing your hazard analysis worksheets, we are unable to tell which, if any, of your prerequisite programs are preventive controls for which you apply the required preventive control management components. It is standard practice when conducting a hazard analysis to have a column that clearly identifies the preventive control for an identified hazard (i.e., distinguishes them from other measures/programs that contribute to safety). For an example, see the Food Safety Plan Example for Omelets in Appendix 3 of the Food Safety Preventive Controls Alliance training manual, available free online. Also, in the “Hummus Process – Hazard Analysis Worksheet” the column to the right of the “Specific control measures” is titled “Is the preventive control applied at this step?;” this column has an “X” in the “Yes” column for every step in the process, suggesting you consider all the controls listed as prerequisite programs to be preventive controls. However, this appears unlikely because some of the prerequisite programs listed are verification activities rather than preventive control measures for specific hazards (e.g., COA verification, test ingredient). In addition, we are unable to determine which of the control measures apply to which hazards since your table groups hazards and control measures together. Specifically,
Mr. Joey Bergstein
President & CEO
Sabra Dipping Company, LLC
777 Westchester Avenue, Third Floor
White Plains, NY 10604-3520
United States
Issuing Office:
Division of Human and Animal Food Operations East II
United States
WARNING LETTER
CMS #615938
December 1, 2021
Dear Mr. Bergstein:
The United States Food and Drug Administration (FDA) and Virginia Department of Agriculture and Consumer Services (VDACS) jointly inspected your ready-to-eat (RTE) hummus manufacturing facility located at 15900 Sabra Way, South Chesterfield, Virginia, from April 28, 2021 through May 6, 2021. The inspection was initiated by FDA and VDACS after FDA Investigators collected a sample of Sabra Classic Hummus from retail and subsequent testing revealed the sample contained Salmonella enterica serovar Havana Group G (hereinafter Salmonella Havana). After being notified by FDA on March 26, 2021, you initiated a Class I voluntary recall of your Sabra Classic Hummus product.
During a joint inspection of your facility, FDA and VDACS Investigators found serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (CGMP & PC rule), Title 21, Code of Federal Regulations, Part 117 (21 CFR Part 117). At the conclusion of the inspection, the Investigators issued you an FDA Form 483, Inspectional Observations. Based on FDA’s inspectional findings, we have determined that the RTE hummus products manufactured in your facility are adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 342(a)(4)], in that they were prepared, packed or held under insanitary conditions whereby they may have been contaminated with filth or rendered injurious to health. In addition, failure of the owner, operator, or agent in charge of a covered facility to comply with the preventive controls provisions of the CGMP & PC rule (located in subparts A, C, D, E, F, and G of part 117) is prohibited by section 301(uu) of the Act [21 U.S.C. § 331(uu)].
Additionally, the presence of Salmonella Havana in your RTE hummus products, as evidenced by the laboratory analysis of FDA’s retail sampling, causes your recalled Classic hummus products to be adulterated within the meaning of section 402(a)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 342(a)(1)] in that they bear or contain an added poisonous or deleterious substance which may render them injurious to health. You may find the Act and further information about the CGMP & PC rule through links in FDA’s home page at www.fda.gov.External Link Disclaimer
We received your written responses on May 27, 2021 and July 8, 2021, which describe your completed and planned corrective actions. After reviewing the inspectional findings and responses you provided, we are issuing this letter to advise you of FDA’s concerns and provide detailed information describing the findings at your facility.
Hazard Analysis and Risk-Based Preventive Controls (21 CFR Part 117, Subpart C)
1. Your hazard analysis did not appropriately identify and evaluate known or reasonably foreseeable hazards to determine whether they require a preventive control, as required by 21 CFR 117.130(a)(1).
Your hazard analyses “Hummus Ingredient – Hazard Analysis Worksheet” dated April 26, 2021 (Version #07) and “Hummus Process – Hazard Analysis Worksheet” dated March 19, 2021 (Version #07) do not clearly indicate whether you determined that a hazard you have identified and evaluated requires a preventive control (except at limited steps where you have identified a CCP). You include an evaluation of identified potential hazards to assess “likelihood/severity” and their specific “risk” (e.g., “low risk,” “high risk”), but your forms do not specifically indicate whether you have determined that a hazard requires a preventive control. Your hazard analysis worksheets, under the column header “Specific control measure to eliminate or acceptably reduce the hazard,” list measures that you call “Pre-Requisite Programs.” The terminology in this column header is consistent with the definition of “preventive controls” in 21 CFR 117.3. In reviewing your hazard analysis worksheets, we are unable to tell which, if any, of your prerequisite programs are preventive controls for which you apply the required preventive control management components. It is standard practice when conducting a hazard analysis to have a column that clearly identifies the preventive control for an identified hazard (i.e., distinguishes them from other measures/programs that contribute to safety). For an example, see the Food Safety Plan Example for Omelets in Appendix 3 of the Food Safety Preventive Controls Alliance training manual, available free online. Also, in the “Hummus Process – Hazard Analysis Worksheet” the column to the right of the “Specific control measures” is titled “Is the preventive control applied at this step?;” this column has an “X” in the “Yes” column for every step in the process, suggesting you consider all the controls listed as prerequisite programs to be preventive controls. However, this appears unlikely because some of the prerequisite programs listed are verification activities rather than preventive control measures for specific hazards (e.g., COA verification, test ingredient). In addition, we are unable to determine which of the control measures apply to which hazards since your table groups hazards and control measures together. Specifically,
a. You did not clearly indicate whether you determined that pathogens such as Salmonella in your tahini ingredient are a hazard requiring a preventive control. Your facility manufactures various RTE hummus products using ingredients such as tahini that are considered RTE and do not undergo further processing in your facility to significantly minimize pathogens prior to inclusion into your finished product.
Your “Hummus Ingredient – Hazard Analysis Worksheet” dated April 26, 2021 (Version #07) lists biological hazards, including several pathogenic sporeformers and Salmonella (which you have identified as “low risk”) for tahini. You list “Pre-Requisite Programs” that include “COA verification, Supplier Approval Program, and Internal Pathogen Testing Program” as “specific control measures to eliminate or acceptably reduce the hazard.” Your “Hummus Process – Hazard Analysis Worksheet” dated March 19, 2021 (Version #07) Section 3 for the Tahini Process lists “pathogens such as Salmonella from the sesame seed” as a biological hazard (which is identified as both “medium risk” and “high risk” at different points in your processing). You list “Pre-Requisite Programs” that include “Internal Testing (b)(4) Program, Supplier Approval Policy, Supplier Questionnaire, COA verification,” as “specific control measures to eliminate or acceptably reduce the hazard.”
Tahini has a known history of contamination with Salmonella, and you should have identified it as a hazard that requires a preventive control, i.e., a supply-chain control, as required by 21 CFR 117.405(a)(1) for a hazard that is controlled by a supplier. It is not clear whether your evaluation of the hazards at the tahini receiving step determined the need for required preventive controls.
Furthermore, the need to evaluate the hazard of pathogens in your tahini is illustrated by your recent Reportable Food Registry (RFR) report received on August 27, 2021. Your RFR report noted that on June 14, 2021 you received (b)(4) lots of tahini ingredient from (b)(4). Samples from the tahini ingredients were analyzed by (b)(4), which identified a (b)(4) value of (b)(4) for each of the lots. (b)(4) performed further analysis on these samples and confirmed findings of Salmonella Havana. You placed these lots on hold, and our investigators witnessed the destruction of this ingredient on September 2, 2021.
b. You did not identify and evaluate whether environmental pathogens are a hazard requiring a preventive control, in accordance with 21 CFR 117.130(c)(ii). You manufacture RTE food products (multiple varieties of hummus) that are exposed to the environment at filling where the food could be contaminated with environmental pathogens, such as L. monocytogenes or Salmonella, and the food does not receive a treatment or otherwise include a control measure (such as a formulation lethal to the pathogen) that would significantly minimize the pathogen. At your multiple filling steps you have identified the biological hazard of “microorganism” as “high risk,” but it is not clear whether your evaluation of these hazards determined the need for required preventive controls. Previous facility inspections jointly conducted by FDA and VDACS in 2016 and 2017 have resulted in the isolation of L. monocytogenes in your processing environment, including swabs collected from direct food-contact surface areas. Furthermore in 2015, a retail sample of Sabra Classic Hummus collected by Michigan Department of Agriculture and Rural Development revealed the sample contained L. monocytogenes. Thus, you should have identified environmental pathogens as a hazard requiring a preventive control.
Sanitation controls for environmental pathogens are necessary when RTE foods are exposed to the environment and there are no subsequent steps that would significantly minimize the hazard. Your “Hummus Process – Hazard Analysis Worksheet” dated March 19, 2021 (Version #07) lists “Pre-Requisite Programs” which include “(b)(4)/Finished Product/Micro Testing/Environmental Swabbing,” “SSOP/Employee Training,” and “Preventative Maintenance Program,” at the filling processing steps where food is exposed to the environment. These measures, although contributing to the control of environmental recontamination, do not replace the need for sanitation preventive controls.
For RTE foods exposed to the environment prior to packaging, where there is no subsequent control for an environmental pathogen, SSOPs are considered sanitation preventive controls that are verified by environmental monitoring. Environmental monitoring (e.g., your facility-specific “Environmental Microbiological Monitoring Program”) is needed to verify that sanitation preventive controls are designed and functioning to reduce the hazard of environmental pathogens contaminating your finished product.
Your “Hummus Ingredient – Hazard Analysis Worksheet” dated April 26, 2021 (Version #07) lists biological hazards, including several pathogenic sporeformers and Salmonella (which you have identified as “low risk”) for tahini. You list “Pre-Requisite Programs” that include “COA verification, Supplier Approval Program, and Internal Pathogen Testing Program” as “specific control measures to eliminate or acceptably reduce the hazard.” Your “Hummus Process – Hazard Analysis Worksheet” dated March 19, 2021 (Version #07) Section 3 for the Tahini Process lists “pathogens such as Salmonella from the sesame seed” as a biological hazard (which is identified as both “medium risk” and “high risk” at different points in your processing). You list “Pre-Requisite Programs” that include “Internal Testing (b)(4) Program, Supplier Approval Policy, Supplier Questionnaire, COA verification,” as “specific control measures to eliminate or acceptably reduce the hazard.”
Tahini has a known history of contamination with Salmonella, and you should have identified it as a hazard that requires a preventive control, i.e., a supply-chain control, as required by 21 CFR 117.405(a)(1) for a hazard that is controlled by a supplier. It is not clear whether your evaluation of the hazards at the tahini receiving step determined the need for required preventive controls.
Furthermore, the need to evaluate the hazard of pathogens in your tahini is illustrated by your recent Reportable Food Registry (RFR) report received on August 27, 2021. Your RFR report noted that on June 14, 2021 you received (b)(4) lots of tahini ingredient from (b)(4). Samples from the tahini ingredients were analyzed by (b)(4), which identified a (b)(4) value of (b)(4) for each of the lots. (b)(4) performed further analysis on these samples and confirmed findings of Salmonella Havana. You placed these lots on hold, and our investigators witnessed the destruction of this ingredient on September 2, 2021.
b. You did not identify and evaluate whether environmental pathogens are a hazard requiring a preventive control, in accordance with 21 CFR 117.130(c)(ii). You manufacture RTE food products (multiple varieties of hummus) that are exposed to the environment at filling where the food could be contaminated with environmental pathogens, such as L. monocytogenes or Salmonella, and the food does not receive a treatment or otherwise include a control measure (such as a formulation lethal to the pathogen) that would significantly minimize the pathogen. At your multiple filling steps you have identified the biological hazard of “microorganism” as “high risk,” but it is not clear whether your evaluation of these hazards determined the need for required preventive controls. Previous facility inspections jointly conducted by FDA and VDACS in 2016 and 2017 have resulted in the isolation of L. monocytogenes in your processing environment, including swabs collected from direct food-contact surface areas. Furthermore in 2015, a retail sample of Sabra Classic Hummus collected by Michigan Department of Agriculture and Rural Development revealed the sample contained L. monocytogenes. Thus, you should have identified environmental pathogens as a hazard requiring a preventive control.
Sanitation controls for environmental pathogens are necessary when RTE foods are exposed to the environment and there are no subsequent steps that would significantly minimize the hazard. Your “Hummus Process – Hazard Analysis Worksheet” dated March 19, 2021 (Version #07) lists “Pre-Requisite Programs” which include “(b)(4)/Finished Product/Micro Testing/Environmental Swabbing,” “SSOP/Employee Training,” and “Preventative Maintenance Program,” at the filling processing steps where food is exposed to the environment. These measures, although contributing to the control of environmental recontamination, do not replace the need for sanitation preventive controls.
For RTE foods exposed to the environment prior to packaging, where there is no subsequent control for an environmental pathogen, SSOPs are considered sanitation preventive controls that are verified by environmental monitoring. Environmental monitoring (e.g., your facility-specific “Environmental Microbiological Monitoring Program”) is needed to verify that sanitation preventive controls are designed and functioning to reduce the hazard of environmental pathogens contaminating your finished product.
c. You did not clearly identify whether you determined that biological hazards are a hazard requiring a preventive control for your spice and seasoning ingredients, e e.g., your crushed red pepper and turmeric. Your “Hummus Ingredient – Hazard Analysis Worksheet” dated April 26, 2021 (Version #07) lists biological hazards, including several pathogenic sporeformers and Salmonella, for a number of spices and seasonings, including your crushed red pepper and turmeric, which you have identified as “medium risk,” and cilantro powder, which you have identified as “low risk.” You list “Pre-Requisite Programs” that include “heat treatment at processing step,” as well as other measures such as COA verification and supplier approval program, as specific control measures to eliminate or acceptably reduce the hazard. You did not explicitly identify whether any of the hazards require a preventive control or whether you consider any of these control measures as preventive controls and apply the preventive control management components required by 21 CFR 117.140.
Furthermore, your “Hummus Ingredient – Hazard Analysis Worksheet” dated April 26, 2021 (Version #07) lists biological hazards, including several pathogenic sporeformers and Salmonella, for a number of (b)(4) spices that you receive (e.g., (b)(4) black pepper, cumin powder, smoked paprika) which you have identified as “medium risk.” You list “Pre-Requisite Programs” that include “heat treatment at processing step” and “(b)(4) at the supplier,” as well as other measures such as COA verification and supplier approval program, as specific control measures to eliminate or acceptably reduce the hazard. We are unclear whether you determined these hazards require a preventive control or whether you consider any of these control measures as preventive controls. Both (b)(4) by a supplier and heat processing at your facility could be considered preventive controls for hazards such as Salmonella, but the controls would be managed differently.
d. You did not clearly identify whether you determined that biological hazards in your frozen vegetable ingredients are a hazard requiring a preventive control. Your “Hummus Ingredient – Hazard Analysis Worksheet” dated April 26, 2021 (Version #07) lists biological hazards, including several pathogenic sporeformers and Salmonella, for frozen vegetables such as IQF white onion, IQF yellow onion and IQF tomatillos, which you have identified as “medium risk.” You list “Pre-Requisite Programs” that include “heat treatment at processing step,” as well as other measures such as COA verification and supplier approval program, as specific control measures to eliminate or acceptably reduce the hazard. We are unclear whether you determined these hazards require a preventive control or whether you consider any of these control measures as preventive controls and apply the preventive control management components required by 21 CFR 117.140.
e. You did not clearly identify whether you determined that biological hazards in your garlic ingredient are a hazard requiring a preventive control. Your “Hummus Process – Hazard Analysis Worksheet” dated 3/19/21 (Version #07) lists the biological hazards of “Pathogens/Spoilage org” for your garlic process step specified at “(b)(4).” At this step you state that “(b)(4) heats the garlic paste more than (b)(4) degrees Fahrenheit.” However, at this step you list the following “Pre-Requisite Programs”: “Test ingredients/Environmental Program/SSOP/ Employee Training/Preventive Maintenance/Metal Detection at Later Step,” as specific control measures to eliminate or acceptably reduce the hazards. We note that your “Pre-Requisite Programs” do not include your heating process. This garlic is subsequently incorporated into the hummus at the mixing step, and the hummus does not receive an additional lethal processing. Thus, it appears that the heating step is a preventive control, but you have not indicated that it is.
2. You did not establish and implement adequate written verification procedures for environmental monitoring, as required by 21 CFR 117.165(b).
Your Environmental Microbiological Monitoring Program, dated June 16, 2020, states that your environmental monitoring for Zone 1 areas includes performing, “Finished Product (b)(4) testing with (b)(4)” at a frequency of “(b)(4) of Hummus (b)(4) every (b)(4),” which totals “(b)(4) per (b)(4).” In addition to testing Zone 1 for coliforms, it appears that you also frequently test samples of finished product using the (b)(4) in Zone 1. (We note that your (b)(4) Sample Collection Plan dated 3/24/21 specifies (b)(4) every (b)(4).) Although your Environmental Microbiological Monitoring Program does include the corrective action procedures you will take for the presence of an environmental pathogen or appropriate indicator organism detected through the environmental monitoring, it does not include corrective action procedures for the presence of a pathogen or appropriate indicator organism in a ready-to-eat product detected as a result of product testing, as required by 21 CFR 117.150(a)(1). We previously reviewed your validation study titled, “Validation of the (b)(4) for (b)(4) Testing (b)(4) as a (b)(4) test in (b)(4) portions of Sabra Classic Hummus,” issued on May 27, 2015, and our current understanding is that (b)(4) greater than or equal to (b)(4) would indicate a positive correlation to the presence a pathogen.
During our inspection, we reviewed your (b)(4) test results from April 2020 through July 2020 and found eleven (11) instances where your RTE hummus finished product testing resulted in (b)(4) greater than (b)(4). According to your validation study, this result would indicate a positive correlation to the presence of a pathogen. In response to these findings, you stated that you isolated and destroyed these lots (the (b)(4) period that tested positive and the (b)(4) period before and after this). When our Investigators asked you to provide records documenting your corrective actions, we found that you did not have any written documentation that these corrective actions were taken.
Additionally, your Environmental Microbiological Monitoring Program dated June 16, 2020 indicates that (b)(4) you will collect (b)(4) samples (swabs) from Zones 2, 3, and 4 to test for Listeria spp. For positive findings, your corrective actions list a number of procedures, including “Areas found to be contaminated must be re-tested until confirmed (b)(4) negatives,” and “management will be immediately notified of a positive result upon receipt of the report.” The procedure further states “The management team will review and assess the risk of contamination to the product. These decisions and minutes will be recorded with the corrective action forms.” In reviewing your firm’s environmental monitoring program records, your Quality Supervisor noted that from April 2020 through April 2021, (b)(4) swabs were collected and analyzed for Listeria spp. and (b)(4) came back positive. Our Investigators reviewed your corrective action forms titled “Form-QA054 Environmental Notification” for six of these positive sites and observed that the management review sections of all six assessment records were blank. Additionally, your records did not indicate whether retesting occurred.
Your corrective action response dated May 27, 2021 indicates that you have developed a new SOP: “Standard Process for Finished Product (b)(4) Rejection and Remediation Version 01,” dated 5/23/21, which outlines action items when a finished product test results in a (b)(4) greater than or equal to (b)(4). Your procedure details the destruction of implicated products, including products manufactured (b)(4) before and (b)(4) after the implicated product test. However, you did not provide any justification to support why the impacted product would be limited to the (b)(4) period before and after a (b)(4) > (b)(4). Additionally, you indicated you will create an incident and CAPA report that will include a most probable root cause and document the steps taken to reach that conclusion, and you will retrain your employees. You have also updated your Form-QA054 Environmental Notification and your SOP-SAN 300 Environmental Sanitation Evaluation Procedures, and you will work to document corrective actions. We will verify the adequacy of your corrective actions during our next inspection.
Furthermore, your “Hummus Ingredient – Hazard Analysis Worksheet” dated April 26, 2021 (Version #07) lists biological hazards, including several pathogenic sporeformers and Salmonella, for a number of (b)(4) spices that you receive (e.g., (b)(4) black pepper, cumin powder, smoked paprika) which you have identified as “medium risk.” You list “Pre-Requisite Programs” that include “heat treatment at processing step” and “(b)(4) at the supplier,” as well as other measures such as COA verification and supplier approval program, as specific control measures to eliminate or acceptably reduce the hazard. We are unclear whether you determined these hazards require a preventive control or whether you consider any of these control measures as preventive controls. Both (b)(4) by a supplier and heat processing at your facility could be considered preventive controls for hazards such as Salmonella, but the controls would be managed differently.
d. You did not clearly identify whether you determined that biological hazards in your frozen vegetable ingredients are a hazard requiring a preventive control. Your “Hummus Ingredient – Hazard Analysis Worksheet” dated April 26, 2021 (Version #07) lists biological hazards, including several pathogenic sporeformers and Salmonella, for frozen vegetables such as IQF white onion, IQF yellow onion and IQF tomatillos, which you have identified as “medium risk.” You list “Pre-Requisite Programs” that include “heat treatment at processing step,” as well as other measures such as COA verification and supplier approval program, as specific control measures to eliminate or acceptably reduce the hazard. We are unclear whether you determined these hazards require a preventive control or whether you consider any of these control measures as preventive controls and apply the preventive control management components required by 21 CFR 117.140.
e. You did not clearly identify whether you determined that biological hazards in your garlic ingredient are a hazard requiring a preventive control. Your “Hummus Process – Hazard Analysis Worksheet” dated 3/19/21 (Version #07) lists the biological hazards of “Pathogens/Spoilage org” for your garlic process step specified at “(b)(4).” At this step you state that “(b)(4) heats the garlic paste more than (b)(4) degrees Fahrenheit.” However, at this step you list the following “Pre-Requisite Programs”: “Test ingredients/Environmental Program/SSOP/ Employee Training/Preventive Maintenance/Metal Detection at Later Step,” as specific control measures to eliminate or acceptably reduce the hazards. We note that your “Pre-Requisite Programs” do not include your heating process. This garlic is subsequently incorporated into the hummus at the mixing step, and the hummus does not receive an additional lethal processing. Thus, it appears that the heating step is a preventive control, but you have not indicated that it is.
2. You did not establish and implement adequate written verification procedures for environmental monitoring, as required by 21 CFR 117.165(b).
Your Environmental Microbiological Monitoring Program, dated June 16, 2020, states that your environmental monitoring for Zone 1 areas includes performing, “Finished Product (b)(4) testing with (b)(4)” at a frequency of “(b)(4) of Hummus (b)(4) every (b)(4),” which totals “(b)(4) per (b)(4).” In addition to testing Zone 1 for coliforms, it appears that you also frequently test samples of finished product using the (b)(4) in Zone 1. (We note that your (b)(4) Sample Collection Plan dated 3/24/21 specifies (b)(4) every (b)(4).) Although your Environmental Microbiological Monitoring Program does include the corrective action procedures you will take for the presence of an environmental pathogen or appropriate indicator organism detected through the environmental monitoring, it does not include corrective action procedures for the presence of a pathogen or appropriate indicator organism in a ready-to-eat product detected as a result of product testing, as required by 21 CFR 117.150(a)(1). We previously reviewed your validation study titled, “Validation of the (b)(4) for (b)(4) Testing (b)(4) as a (b)(4) test in (b)(4) portions of Sabra Classic Hummus,” issued on May 27, 2015, and our current understanding is that (b)(4) greater than or equal to (b)(4) would indicate a positive correlation to the presence a pathogen.
During our inspection, we reviewed your (b)(4) test results from April 2020 through July 2020 and found eleven (11) instances where your RTE hummus finished product testing resulted in (b)(4) greater than (b)(4). According to your validation study, this result would indicate a positive correlation to the presence of a pathogen. In response to these findings, you stated that you isolated and destroyed these lots (the (b)(4) period that tested positive and the (b)(4) period before and after this). When our Investigators asked you to provide records documenting your corrective actions, we found that you did not have any written documentation that these corrective actions were taken.
Additionally, your Environmental Microbiological Monitoring Program dated June 16, 2020 indicates that (b)(4) you will collect (b)(4) samples (swabs) from Zones 2, 3, and 4 to test for Listeria spp. For positive findings, your corrective actions list a number of procedures, including “Areas found to be contaminated must be re-tested until confirmed (b)(4) negatives,” and “management will be immediately notified of a positive result upon receipt of the report.” The procedure further states “The management team will review and assess the risk of contamination to the product. These decisions and minutes will be recorded with the corrective action forms.” In reviewing your firm’s environmental monitoring program records, your Quality Supervisor noted that from April 2020 through April 2021, (b)(4) swabs were collected and analyzed for Listeria spp. and (b)(4) came back positive. Our Investigators reviewed your corrective action forms titled “Form-QA054 Environmental Notification” for six of these positive sites and observed that the management review sections of all six assessment records were blank. Additionally, your records did not indicate whether retesting occurred.
Your corrective action response dated May 27, 2021 indicates that you have developed a new SOP: “Standard Process for Finished Product (b)(4) Rejection and Remediation Version 01,” dated 5/23/21, which outlines action items when a finished product test results in a (b)(4) greater than or equal to (b)(4). Your procedure details the destruction of implicated products, including products manufactured (b)(4) before and (b)(4) after the implicated product test. However, you did not provide any justification to support why the impacted product would be limited to the (b)(4) period before and after a (b)(4) > (b)(4). Additionally, you indicated you will create an incident and CAPA report that will include a most probable root cause and document the steps taken to reach that conclusion, and you will retrain your employees. You have also updated your Form-QA054 Environmental Notification and your SOP-SAN 300 Environmental Sanitation Evaluation Procedures, and you will work to document corrective actions. We will verify the adequacy of your corrective actions during our next inspection.
3. You did not take corrective action for an unanticipated food safety problem as described in 21 CFR 117.150(b)(1)(ii) when a preventive control, combination of preventive controls, or the food safety plan as a whole is found to be ineffective to identify and correct the problem, reduce the likelihood that the problem will recur, evaluate all affected food for safety, and when appropriate, reanalyze the food safety plan, as required by 21 CFR 117.150(b)(2).
Specifically, on March 26, 2021, you were notified by FDA of a retail sample of Classic Hummus collected in California that tested positive for Salmonella Havana. In response to these findings, you initiated a Class I recall of your Classic Hummus products, which consisted of approximately 16,200 pounds (25,920 10oz cups) of product that was distributed in seventeen states. Whole genome sequencing of these findings found that this isolate did not match any isolate in our database. FDA advised you of these findings on May 4, 2021. During our inspection, we followed up on the corrective actions that were taken in response to these findings. We documented that you conducted a root cause investigation, as described in “S2021 RCA Investigation Summary,” but reported to FDA that you were unable to identify a root cause for the problem. Additionally, during our inspection, Investigators found that you identified sixteen observations to be corrected by April 26, 2021. These observations mainly include reviewing your SOP and GMP practices for high care areas and retraining your employees. However, review of your documentation showed that only two of the sixteen corrections were complete by the close of our inspection on May 6, 2021. To date, no additional information on the completion of these corrective actions has been provided. In addition, we note that the root cause analysis described in the Summary did not include an investigation of your suppliers. Further, we note that your corrective actions did not indicate that you conducted a reanalysis of your food safety plan.
The Agency is very concerned about the findings of Salmonella in your finished product. We acknowledge your voluntary recall and proposed corrective action recommendations. However, in addition to correcting the deviations cited in this letter, we strongly recommend that you conduct an in-depth analysis of all aspects of your food safety plan and take robust corrective action in the event of an unanticipated food safety problem to prevent the reoccurrence.
Hazard Analysis and Risk-Based Preventive Controls- Supply-Chain Program (21 CFR Part 117, Subpart G)
1. Your facility manufactures various RTE hummus products using ingredients, such as tahini, that have a known or reasonably foreseeable hazard of pathogens (e.g., Salmonella) and do not receive any further processing in your facility to control these hazards. For ingredients that have a hazard requiring a preventive control, and that hazard is controlled prior to receipt (and the ingredients do not receive any further processing in your facility to address the hazard), you are required to establish and implement a supply-chain program in accordance with 21 CFR part 117, subpart G to provide assurance that the hazards requiring a supply-chain-applied control for the raw material or other ingredient have been significantly minimized or prevented (see 21 CFR 117.405(a)(1) and 410(c)). Your Supplier Approval Policy (Version 11, date 4/18/2019) specifies that current third-party audits must be submitted to Sabra (b)(4) and that all high-risk ingredients will be audited by Sabra or a designated third-party auditor (b)(4).
Based on your Tahini Sampling Plan (Hold and Release) dated January 13, 2021, it is our understanding that you currently have (b)(4) suppliers for your tahini ingredient, (b)(4), and you utilized third party contracts to conduct on-site audits. A review of the most recent third-party audit conducted at (b)(4), from January 25-29, 2021, reveals that the scope of that audit covered roasting peanuts but not the manufacturing of the tahini ingredient, including the toasted sesame seed operation. Toasted sesame seeds are the main ingredient your supplier uses to manufacture the tahini, and the toasting of the seeds is the preventive control for Salmonella in sesame seeds. The audit must include a review of the supplier's written plan (e.g., Hazard Analysis and Critical Control Point (HACCP) plan or other food safety plan), if any, and its implementation, for the hazard being controlled for the raw material or other ingredient provided by the supplier, as required by 21 CFR 117.435(b).
Current Good Manufacturing Practice (21 CFR Part 117, Subpart B)
1. You did not conduct all food manufacturing, processing, packing, and holding under such conditions and controls as are necessary to minimize the potential for contamination of food, as required by 21 CFR 117.80(c)(2).
Our Investigators observed employees mishandling the (b)(4) that is used to unload tahini (a RTE food ingredient) from bulk totes to your tahini storage system. Specifically, investigators observed that the (b)(4) was not cleaned before use and came in contact with the exterior of the tahini tote. Additionally, materials used to clean the interior and exterior of the (b)(4), such as (b)(4) used to cover the (b)(4) between unloading activities, gloves, and wipes, were stored on a walking surface. In your corrective actions response of May 27, 2021, you state that your firm has established a tahini unloading procedure “SOP-OPS Conventional Tahini (b)(4) System” dated 5/24/21. We will verify the adequacy of these corrective actions during our next inspection.
In addition to the violations described above, we offer the following comments:
On September 1, 2021, FDA collected a retail sample of your Roasted Red Pepper Hummus that tested positive for Listeria innocua, a non-pathogenic Listeria species. The presence of Listeria species such as Listeria innocua suggests that conditions in your facility also are suitable for survival and/or growth of Listeria monocytogenes. This finding may indicate a sanitation failure or a breakdown in your food safety plan and further contributes to the Agency’s concerns about your written food safety plan. You responded to these findings on September 27, 2021, outlining your proposed corrective actions, but subsequently have not provided additional information regarding the implementation of your proposed corrective actions. We strongly advise that you take robust corrective actions to address this finding.
Column 4 of your hazard analysis (“Hummus Process – Hazard Analysis Worksheet” dated March 19, 2021 (Version #07)) is intended for you to “Justify your decision in column 3”, however no such justification is provided for any processing steps. Instead, various information is presented in this column about what happens at the processing step, but in most cases, it is unclear why that information is presented or to what potential hazard it is relevant.
It is our understanding that your facility’s RTE hummus products could contain garnishes with allergens that include tree nuts (pine nut) (pine nuts are listed as “high risk” in your “Hummus Ingredient – Hazard Analysis Worksheet” dated April 26, 2021 (Version #07)). Your “Hummus Process – Hazard Analysis Worksheet” dated 3/19/21 (Version #07) does not contain an explanation of why you determined that prerequisite programs are the “specific control measures” for allergens and does not identify a preventive control at the processing steps where equipment and utensils are used for food with and without pine nuts to prevent allergen cross-contact. You have a prerequisite program at these steps that includes an “Allergen Control Program” and “SSOP.” It appears that your allergen control program and cleaning SSOP may be the basis for you concluding that you do not need preventive controls for allergen cross-contact. Preventive controls are “those risk-based, reasonably appropriate procedures, practices, and processes that a person knowledgeable about the safe manufacturing, processing, packing, or holding of food would employ to significantly minimize or prevent the hazards identified under the hazard analysis that are consistent with the current scientific understanding of safe food manufacturing, processing, packing, or holding at the time of the analysis.” Thus, we would consider these programs to be preventive controls for allergens.
You did not identify and evaluate undeclared allergens due to incorrect labeling as a known or reasonably foreseeable hazard to determine whether it is a hazard requiring a preventive control, although you do check your labels prior to use on the production line (a preventive control for undeclared allergens).
During our inspection, our Investigator observed apparent water droplets on the ceiling directly above filler (b)(4), inside the filler (b)(4), and on the underside of a metal plate at the hummus fill station above exposed product. During a management discussion it was reported that this liquid was a (b)(4) sanitizer that was applied after a CIP process occurred in the morning. The (b)(4) sanitizer’s label directions state that for non-food contact surfaces such as walls and ceilings, the product should be allowed to dry prior to operations. Dripping liquids in locations directly over exposed product present potential vectors for cross- contamination. Dripping liquid over your filling station was an observation that was discussed with your management during our 2016 inspection. Our investigator noted that you do not have a procedure to ensure that these areas are dry prior to resuming filling operations.
As described in 21 CFR 117.165 (a)(2), product testing can be an appropriate verification that preventive controls are consistently implemented and are effectively and significantly minimizing or preventing hazards. Product testing cannot be used as a substitute for properly designed and implemented preventive controls. The recent identification of Salmonella Havana in your tahini ingredient (by you) and in your finished product at retail (by the Agency), along with the other issues noted in this letter and during the inspections of your facility, should be considered in reanalyzing your food safety plan.
As you work to address the violations cited in the Warning Letter, we remind you that preventive controls must include preventive control management components (monitoring, corrective action, verification) as appropriate to ensure the effectiveness of the preventive controls, taking into account the nature of the preventive control and its role in the facility's food safety system, as required by 21 CFR 117.140.
The violations cited in this letter are not intended to be an all-inclusive list of violations that exist at your facility or in connection with your products. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure your facility complies with all requirements of federal law, including FDA regulations. You should take prompt action to correct or implement corrections to the violations cited in this letter. Failure to do so may result in legal action without further notice, including, without limitation, seizure, injunction, or administrative action for suspension of food facility registration if criteria and conditions warrant.
Please notify FDA in writing, within 15 working days of the receipt of this letter, of the specific steps you have taken to address these violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration. If you cannot complete addressing these violations within 15 working days, state the reason for the delay and the timeframe within which you will do so.
Section 743 of the Act, (21 USC 379j-31), authorizes FDA to assess and collect fees to cover FDA's costs for certain activities, including re-inspection-related costs. A re-inspection is one or more inspections conducted subsequent to an inspection that identified non-compliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Re-inspection-related costs means all expenses, including administrative expenses incurred in connection with FDA's arranging, conducting, and evaluating the results of the reinspection and assessing and collecting the re-inspection fees, [21 USC 379j-31(a)(2)(B)]. For a domestic facility, FDA will assess and collect fees for re-inspection-related costs from the responsible party for the domestic facility. The inspection noted in this letter identified non-compliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection-related costs.
Your written response should be sent to Compliance Officer Jessica Weber at United States Food & Drug Administration, 11155 Dolfield Boulevard, Suite 117, Owings Mills, Maryland 21117. An emailed response is also acceptable. Files greater than 100 megabytes may be submitted as smaller files in separate emails. If you have questions regarding this letter, please contact CO Weber by telephone at (410) 779-5407, or by email at jessica.weber@fda.hhs.gov.
Sincerely,
/S/
Randy F. Pack
District Director/Program Division Director
Baltimore District Office
Human & Animal Food East, Division 2
Office of Regulatory Affairs
U.S. Food and Drug Administration
randy.pack@fda.hhs.gov
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Specifically, on March 26, 2021, you were notified by FDA of a retail sample of Classic Hummus collected in California that tested positive for Salmonella Havana. In response to these findings, you initiated a Class I recall of your Classic Hummus products, which consisted of approximately 16,200 pounds (25,920 10oz cups) of product that was distributed in seventeen states. Whole genome sequencing of these findings found that this isolate did not match any isolate in our database. FDA advised you of these findings on May 4, 2021. During our inspection, we followed up on the corrective actions that were taken in response to these findings. We documented that you conducted a root cause investigation, as described in “S2021 RCA Investigation Summary,” but reported to FDA that you were unable to identify a root cause for the problem. Additionally, during our inspection, Investigators found that you identified sixteen observations to be corrected by April 26, 2021. These observations mainly include reviewing your SOP and GMP practices for high care areas and retraining your employees. However, review of your documentation showed that only two of the sixteen corrections were complete by the close of our inspection on May 6, 2021. To date, no additional information on the completion of these corrective actions has been provided. In addition, we note that the root cause analysis described in the Summary did not include an investigation of your suppliers. Further, we note that your corrective actions did not indicate that you conducted a reanalysis of your food safety plan.
The Agency is very concerned about the findings of Salmonella in your finished product. We acknowledge your voluntary recall and proposed corrective action recommendations. However, in addition to correcting the deviations cited in this letter, we strongly recommend that you conduct an in-depth analysis of all aspects of your food safety plan and take robust corrective action in the event of an unanticipated food safety problem to prevent the reoccurrence.
Hazard Analysis and Risk-Based Preventive Controls- Supply-Chain Program (21 CFR Part 117, Subpart G)
1. Your facility manufactures various RTE hummus products using ingredients, such as tahini, that have a known or reasonably foreseeable hazard of pathogens (e.g., Salmonella) and do not receive any further processing in your facility to control these hazards. For ingredients that have a hazard requiring a preventive control, and that hazard is controlled prior to receipt (and the ingredients do not receive any further processing in your facility to address the hazard), you are required to establish and implement a supply-chain program in accordance with 21 CFR part 117, subpart G to provide assurance that the hazards requiring a supply-chain-applied control for the raw material or other ingredient have been significantly minimized or prevented (see 21 CFR 117.405(a)(1) and 410(c)). Your Supplier Approval Policy (Version 11, date 4/18/2019) specifies that current third-party audits must be submitted to Sabra (b)(4) and that all high-risk ingredients will be audited by Sabra or a designated third-party auditor (b)(4).
Based on your Tahini Sampling Plan (Hold and Release) dated January 13, 2021, it is our understanding that you currently have (b)(4) suppliers for your tahini ingredient, (b)(4), and you utilized third party contracts to conduct on-site audits. A review of the most recent third-party audit conducted at (b)(4), from January 25-29, 2021, reveals that the scope of that audit covered roasting peanuts but not the manufacturing of the tahini ingredient, including the toasted sesame seed operation. Toasted sesame seeds are the main ingredient your supplier uses to manufacture the tahini, and the toasting of the seeds is the preventive control for Salmonella in sesame seeds. The audit must include a review of the supplier's written plan (e.g., Hazard Analysis and Critical Control Point (HACCP) plan or other food safety plan), if any, and its implementation, for the hazard being controlled for the raw material or other ingredient provided by the supplier, as required by 21 CFR 117.435(b).
Current Good Manufacturing Practice (21 CFR Part 117, Subpart B)
1. You did not conduct all food manufacturing, processing, packing, and holding under such conditions and controls as are necessary to minimize the potential for contamination of food, as required by 21 CFR 117.80(c)(2).
Our Investigators observed employees mishandling the (b)(4) that is used to unload tahini (a RTE food ingredient) from bulk totes to your tahini storage system. Specifically, investigators observed that the (b)(4) was not cleaned before use and came in contact with the exterior of the tahini tote. Additionally, materials used to clean the interior and exterior of the (b)(4), such as (b)(4) used to cover the (b)(4) between unloading activities, gloves, and wipes, were stored on a walking surface. In your corrective actions response of May 27, 2021, you state that your firm has established a tahini unloading procedure “SOP-OPS Conventional Tahini (b)(4) System” dated 5/24/21. We will verify the adequacy of these corrective actions during our next inspection.
In addition to the violations described above, we offer the following comments:
On September 1, 2021, FDA collected a retail sample of your Roasted Red Pepper Hummus that tested positive for Listeria innocua, a non-pathogenic Listeria species. The presence of Listeria species such as Listeria innocua suggests that conditions in your facility also are suitable for survival and/or growth of Listeria monocytogenes. This finding may indicate a sanitation failure or a breakdown in your food safety plan and further contributes to the Agency’s concerns about your written food safety plan. You responded to these findings on September 27, 2021, outlining your proposed corrective actions, but subsequently have not provided additional information regarding the implementation of your proposed corrective actions. We strongly advise that you take robust corrective actions to address this finding.
Column 4 of your hazard analysis (“Hummus Process – Hazard Analysis Worksheet” dated March 19, 2021 (Version #07)) is intended for you to “Justify your decision in column 3”, however no such justification is provided for any processing steps. Instead, various information is presented in this column about what happens at the processing step, but in most cases, it is unclear why that information is presented or to what potential hazard it is relevant.
It is our understanding that your facility’s RTE hummus products could contain garnishes with allergens that include tree nuts (pine nut) (pine nuts are listed as “high risk” in your “Hummus Ingredient – Hazard Analysis Worksheet” dated April 26, 2021 (Version #07)). Your “Hummus Process – Hazard Analysis Worksheet” dated 3/19/21 (Version #07) does not contain an explanation of why you determined that prerequisite programs are the “specific control measures” for allergens and does not identify a preventive control at the processing steps where equipment and utensils are used for food with and without pine nuts to prevent allergen cross-contact. You have a prerequisite program at these steps that includes an “Allergen Control Program” and “SSOP.” It appears that your allergen control program and cleaning SSOP may be the basis for you concluding that you do not need preventive controls for allergen cross-contact. Preventive controls are “those risk-based, reasonably appropriate procedures, practices, and processes that a person knowledgeable about the safe manufacturing, processing, packing, or holding of food would employ to significantly minimize or prevent the hazards identified under the hazard analysis that are consistent with the current scientific understanding of safe food manufacturing, processing, packing, or holding at the time of the analysis.” Thus, we would consider these programs to be preventive controls for allergens.
You did not identify and evaluate undeclared allergens due to incorrect labeling as a known or reasonably foreseeable hazard to determine whether it is a hazard requiring a preventive control, although you do check your labels prior to use on the production line (a preventive control for undeclared allergens).
During our inspection, our Investigator observed apparent water droplets on the ceiling directly above filler (b)(4), inside the filler (b)(4), and on the underside of a metal plate at the hummus fill station above exposed product. During a management discussion it was reported that this liquid was a (b)(4) sanitizer that was applied after a CIP process occurred in the morning. The (b)(4) sanitizer’s label directions state that for non-food contact surfaces such as walls and ceilings, the product should be allowed to dry prior to operations. Dripping liquids in locations directly over exposed product present potential vectors for cross- contamination. Dripping liquid over your filling station was an observation that was discussed with your management during our 2016 inspection. Our investigator noted that you do not have a procedure to ensure that these areas are dry prior to resuming filling operations.
As described in 21 CFR 117.165 (a)(2), product testing can be an appropriate verification that preventive controls are consistently implemented and are effectively and significantly minimizing or preventing hazards. Product testing cannot be used as a substitute for properly designed and implemented preventive controls. The recent identification of Salmonella Havana in your tahini ingredient (by you) and in your finished product at retail (by the Agency), along with the other issues noted in this letter and during the inspections of your facility, should be considered in reanalyzing your food safety plan.
As you work to address the violations cited in the Warning Letter, we remind you that preventive controls must include preventive control management components (monitoring, corrective action, verification) as appropriate to ensure the effectiveness of the preventive controls, taking into account the nature of the preventive control and its role in the facility's food safety system, as required by 21 CFR 117.140.
The violations cited in this letter are not intended to be an all-inclusive list of violations that exist at your facility or in connection with your products. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure your facility complies with all requirements of federal law, including FDA regulations. You should take prompt action to correct or implement corrections to the violations cited in this letter. Failure to do so may result in legal action without further notice, including, without limitation, seizure, injunction, or administrative action for suspension of food facility registration if criteria and conditions warrant.
Please notify FDA in writing, within 15 working days of the receipt of this letter, of the specific steps you have taken to address these violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration. If you cannot complete addressing these violations within 15 working days, state the reason for the delay and the timeframe within which you will do so.
Section 743 of the Act, (21 USC 379j-31), authorizes FDA to assess and collect fees to cover FDA's costs for certain activities, including re-inspection-related costs. A re-inspection is one or more inspections conducted subsequent to an inspection that identified non-compliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Re-inspection-related costs means all expenses, including administrative expenses incurred in connection with FDA's arranging, conducting, and evaluating the results of the reinspection and assessing and collecting the re-inspection fees, [21 USC 379j-31(a)(2)(B)]. For a domestic facility, FDA will assess and collect fees for re-inspection-related costs from the responsible party for the domestic facility. The inspection noted in this letter identified non-compliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection-related costs.
Your written response should be sent to Compliance Officer Jessica Weber at United States Food & Drug Administration, 11155 Dolfield Boulevard, Suite 117, Owings Mills, Maryland 21117. An emailed response is also acceptable. Files greater than 100 megabytes may be submitted as smaller files in separate emails. If you have questions regarding this letter, please contact CO Weber by telephone at (410) 779-5407, or by email at jessica.weber@fda.hhs.gov.
Sincerely,
/S/
Randy F. Pack
District Director/Program Division Director
Baltimore District Office
Human & Animal Food East, Division 2
Office of Regulatory Affairs
U.S. Food and Drug Administration
randy.pack@fda.hhs.gov
Content current as of:
12/07/2021
Regulated Product(s)
Food & Beverages
Warning Letters
About Warning and Close-Out Letters
Footer Links
FDA Archive
About FDA
Accessibility
Visitor Information
Website Policies / Privacy
No FEAR Act
FOIA
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