"FDA collected environmental samples (i.e., swabs) from surfaces in [the] manufacturing facility during this inspection and a subsequent inspection, conducted from January 23, 2024, through February 9, 2024, in response to a consumer complaint. Analysis of these samples using whole genome sequencing revealed that three of the Salmonella-positive environmental swabs collected in the post-process area of [the] facility during the 2024 inspection are closely related to seven Salmonella-positive environmental swabs collected in the pre-process areas of your facility during the 2023 inspection, indicating that [the] facility may have three resident strains of Salmonella: Salmonella Rissen, Salmonella Minnesota, and Salmonella Mbandaka."
- FDA Investigators observed visible debris on food-contact surfaces of equipment such as brushes, brooms, and squeegees after cleaning and sanitizing of equipment was performed by your third-party sanitation service.
- Did not document (b)(4) cleaning for the discharge hoppers located in the packaging area for the entire month of December 2023. In addition, there were multiple instances of other equipment and areas where [employees] did not document sanitation activities in accordance with your Master Cleaning Schedule
- FDA Investigators observed rainwater entering your facility through the roof while manufacturing multiple lots of dog food. FDA Investigators observed standing water and soaked absorbent pads in staging, production, and finished product areas, including in post-process areas such as the dryer room and packaging areas. The manufacturing facility must be constructed in a manner such does not become a source of potential contamination to your animal food.
- Did not document the (b)(4) process control applied to the chicken fat prior to January 13, 2024, which demonstrates the company did not effectively implement your process control.
- Did not take appropriate corrective action when a preventive control, combination of preventive controls, or the food safety plan as a whole was found to be ineffective, specifically in handling situations were positive samples were detected.
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/mid-america-pet-food-llc-681516-11222024
WARNING LETTER
Mid America Pet Food LLC
MARCS-CMS 681516 — November 22, 2024
Recipient:
Jeff Caswell
Chief Executive Officer
Mid America Pet Food LLC
2024 N. Frontage Road
Mount Pleasant, TX 75455-6474
United States
Issuing Office:
Center for Veterinary Medicine
United States
WARNING LETTER
CMS# 681516
November 22, 2024
Dear Mr. Caswell:
The U.S. Food and Drug Administration (FDA) inspected your pet food manufacturing facility located at 2024 N. Frontage Road, Mount Pleasant, Texas from November 2, 2023, through December 18, 2023. FDA also conducted a subsequent inspection from January 23, 2024, through February 9, 2024, at this facility. We received your responses dated January 10, 2024; March 4, 2024; and July 10, 2024, to the FDA 483 Inspectional Observations. FDA conducted the 2023 inspection in response to your voluntary Class I recalls initiated on September 3, 2023, expanded on October 30, 2023, and further expanded on November 9, 2023, to include all your dog and cat food with best by dates before October 31, because they had the potential to be contaminated with Salmonella. In addition, FDA conducted the 2023 inspection as part of an investigation, along with the Centers for Disease Control (CDC) and state and local partners, into a multi-state foodborne illness outbreak of Salmonella Kiambu implicated in human illnesses through epidemiological traceback.1 A total of seven people from seven states were infected with the outbreak strain from January 14, 2023 to August 19, 2023, and one person was hospitalized. Six of the affected people were children under one year of age. Salmonella can affect animals eating the products, and there is risk to humans from handling contaminated pet products and utensils that came into contact with the affected pet products. Children, the elderly, and individuals with compromised immune systems may be at greater risk for Salmonella infection.
These illnesses were linked by whole genome sequencing to dog food manufactured at your facility in 2023 through a sample of Victor Super Premium Dog Food Classic Hi-Pro Plus (lot 1000016385; Best By 4/30/24) collected by the South Carolina Department of Agriculture on August 15, 2023, which you recalled on September 3, 2023. On October 30, 2023, you expanded your initial recall to include Victor Super Premium Dog Food, Select Beef Meal & Brown Rice Formula with best by dates of June 12, 2024 (5 lbs. lot 1000016890; 15 lbs. lot 1000016891; and 40 lbs. lot 1000016892). On November 9, 2023, you expanded your recall to include all products with best by dates before October 31, 2024, because your testing revealed the presence of Salmonella Kiambu in a lot for which you reported receiving a consumer complaint involving human illness. Based on analytical results, FDA considers the Victor Super Premium Dog Food Classic Hi-Pro Plus (lot 1000016385; Best By 4/30/24)lot to be adulterated in that it bears or contains a poisonous or deleterious substance which may render it injurious to health.2
FDA collected environmental samples (i.e., swabs) from surfaces in your manufacturing facility during this inspection and a subsequent inspection, conducted from January 23, 2024, through February 9, 2024, in response to a consumer complaint. Analysis of these samples using whole genome sequencing revealed that three of the Salmonella-positive environmental swabs collected in the post-process area of your facility during the 2024 inspection are closely related to seven Salmonella-positive environmental swabs collected in the pre-process areas of your facility during the 2023 inspection, indicating that your facility may have three resident strains of Salmonella: Salmonella Rissen, Salmonella Minnesota, and Salmonella Mbandaka.
During these inspections FDA Investigators found evidence of significant violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals requirements in Title 21, Code of Federal Regulations, Part 507 (21 CFR Part 507), which cause your products to be adulterated in that they were prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth, or whereby they may have been rendered injurious to health.3 Additionally, the introduction or delivery for introduction into interstate commerce of any food that is adulterated is a prohibited act.4 Furthermore, the failure of the owner, operator, or agent in charge of a covered facility to comply with the preventive controls provisions of 21 CFR 507 (located in subparts A, C, D, E, and F of Part 507) is a prohibited act.5 You may find the FD&C Act and FDA’s regulations through links on the FDA’s website at www.fda.gov.
At the conclusion of our inspections on December 18, 2023, and February 9, 2024, you were issued two separate Forms FDA 483, Inspectional Observations. We received your written responses to these observations dated January 10, 2024, March 4, 2024, and July 10, 2024, and address your corrective actions below, in relation to each of the noted violations.
Hazard Analysis and Risk-Based Preventive Controls Requirements
Your animal food facility is subject to the hazard analysis and risk-based preventive controls requirements found in 21 CFR Part 507, subparts A, C, D, E, and F. During the inspection of your facility, the FDA Investigators obtained evidence of significant violations of these requirements, which included:
1. You did not identify and implement a preventive control to provide assurances that any hazards requiring a preventive control will be significantly minimized or prevented, as required by 21 CFR 507.34(a)(1).
Specifically, your hazard analysis determined the hazard of Salmonella requires preventive controls and identified sanitation and process controls to control the hazard of Salmonella in your finished pet food.
A. Your Food Safety Plan dated January 9, 2024, documents your sanitation control for Salmonella spp. in post-extrusion processing environments by removing residual material on post-extruder surfaces and applying sanitizer in accordance with the sanitizer label. However, you failed to adequately implement your sanitation control.
i. You use (b)(4) as a sanitizer for food-contact equipment and utensils. Your “(b)(4) Procedure” (SOP 1500) standard operating procedure (SOP), dated December 5, 2023, documents, “Surfaces must remain thoroughly wetted for (b)(4) followed by adequate draining and air drying . . . [a]llow the identified surface to air dry before the manufacturing process can resume, or the identified surface is reintroduced for use.” Furthermore, the label for (b)(4) documents “treated surfaces must remain wet for at least (b)(4) followed by adequate draining and air drying” for food-processing equipment and food-contact surfaces. On January 30, 2024, FDA Investigators observed an employee designated to the post-extrusion area cleaning food-contact equipment who used (b)(4) to sanitize the equipment and then immediately dried the surface of the equipment with a paper towel. During this cleaning, the equipment made direct contact with the employee’s clothing which was visibly soiled with apparent dog food.
ii. Your “Housekeeping Procedure” (CGMP 2800),” dated February 2, 2022, documents that the sanitation lead employee write their initials on sanitation records to document their inspection and review of sanitation activities on the Master Cleaning Schedule. Your Master Cleaning Schedule, “Housekeeping #5” for December 2023 does not document (b)(4) cleaning for the discharge hoppers located in the packaging area for the entire month of December 2023.
In addition, there were multiple instances of other equipment and areas where you did not document sanitation activities in accordance with your Master Cleaning Schedule in April 2023, May 2023, June 2023, September 2023, December 2023, and January 2024.
iii. On January 26, 2024, FDA Investigators observed visible debris on food-contact surfaces of equipment such as brushes, brooms, and squeegees after cleaning and sanitizing of equipment was performed by your third-party sanitation service. In addition, you could not produce any sanitation records for July and August of 2023 and your records for April 2023 and May 2023 were incomplete. Your lack of complete records in addition to the ineffective cleaning observed by Investigators demonstrates your failure to implement your sanitation preventive control.
B. Your Food Safety Plan dated January 9, 2024, documents “CGMP controls” to minimize the hazard of Salmonella spp. in post-extrusion processing environments.
i. On January 23, 2024, FDA Investigators observed rainwater entering your facility through the roof while you were manufacturing multiple lots of dog food. FDA Investigators observed standing water and soaked absorbent pads in staging, production, and finished product areas, including in post-process areas such as the dryer room and packaging areas. Your manufacturing facility must be constructed in a manner such does not become a source of potential contamination to your animal food.
C. Your Food Safety Plan dated January 9, 2024, documents your process control for Salmonella spp. at the Storage of Liquid Bulk Ingredients step for chicken fat is to (b)(4) and (b)(4).
i. You did not document the (b)(4) process control applied to your chicken fat prior to January 13, 2024, which demonstrates you did not effectively implement your process control. Your (b)(4) Log (SOP-5800F-(b)(4)), documents that from January 13 through February 4, 2024, you did not routinely (b)(4) in accordance with the validation study you provided for this process. The target (b)(4) listed as a parameter in on the (b)(4) Log is (b)(4), and your records document that you (b)(4) to (b)(4) of (b)(4) truckloads of fat received from January 13 through February 4, 2024.
CMS# 681516
November 22, 2024
Dear Mr. Caswell:
The U.S. Food and Drug Administration (FDA) inspected your pet food manufacturing facility located at 2024 N. Frontage Road, Mount Pleasant, Texas from November 2, 2023, through December 18, 2023. FDA also conducted a subsequent inspection from January 23, 2024, through February 9, 2024, at this facility. We received your responses dated January 10, 2024; March 4, 2024; and July 10, 2024, to the FDA 483 Inspectional Observations. FDA conducted the 2023 inspection in response to your voluntary Class I recalls initiated on September 3, 2023, expanded on October 30, 2023, and further expanded on November 9, 2023, to include all your dog and cat food with best by dates before October 31, because they had the potential to be contaminated with Salmonella. In addition, FDA conducted the 2023 inspection as part of an investigation, along with the Centers for Disease Control (CDC) and state and local partners, into a multi-state foodborne illness outbreak of Salmonella Kiambu implicated in human illnesses through epidemiological traceback.1 A total of seven people from seven states were infected with the outbreak strain from January 14, 2023 to August 19, 2023, and one person was hospitalized. Six of the affected people were children under one year of age. Salmonella can affect animals eating the products, and there is risk to humans from handling contaminated pet products and utensils that came into contact with the affected pet products. Children, the elderly, and individuals with compromised immune systems may be at greater risk for Salmonella infection.
These illnesses were linked by whole genome sequencing to dog food manufactured at your facility in 2023 through a sample of Victor Super Premium Dog Food Classic Hi-Pro Plus (lot 1000016385; Best By 4/30/24) collected by the South Carolina Department of Agriculture on August 15, 2023, which you recalled on September 3, 2023. On October 30, 2023, you expanded your initial recall to include Victor Super Premium Dog Food, Select Beef Meal & Brown Rice Formula with best by dates of June 12, 2024 (5 lbs. lot 1000016890; 15 lbs. lot 1000016891; and 40 lbs. lot 1000016892). On November 9, 2023, you expanded your recall to include all products with best by dates before October 31, 2024, because your testing revealed the presence of Salmonella Kiambu in a lot for which you reported receiving a consumer complaint involving human illness. Based on analytical results, FDA considers the Victor Super Premium Dog Food Classic Hi-Pro Plus (lot 1000016385; Best By 4/30/24)lot to be adulterated in that it bears or contains a poisonous or deleterious substance which may render it injurious to health.2
FDA collected environmental samples (i.e., swabs) from surfaces in your manufacturing facility during this inspection and a subsequent inspection, conducted from January 23, 2024, through February 9, 2024, in response to a consumer complaint. Analysis of these samples using whole genome sequencing revealed that three of the Salmonella-positive environmental swabs collected in the post-process area of your facility during the 2024 inspection are closely related to seven Salmonella-positive environmental swabs collected in the pre-process areas of your facility during the 2023 inspection, indicating that your facility may have three resident strains of Salmonella: Salmonella Rissen, Salmonella Minnesota, and Salmonella Mbandaka.
During these inspections FDA Investigators found evidence of significant violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals requirements in Title 21, Code of Federal Regulations, Part 507 (21 CFR Part 507), which cause your products to be adulterated in that they were prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth, or whereby they may have been rendered injurious to health.3 Additionally, the introduction or delivery for introduction into interstate commerce of any food that is adulterated is a prohibited act.4 Furthermore, the failure of the owner, operator, or agent in charge of a covered facility to comply with the preventive controls provisions of 21 CFR 507 (located in subparts A, C, D, E, and F of Part 507) is a prohibited act.5 You may find the FD&C Act and FDA’s regulations through links on the FDA’s website at www.fda.gov.
At the conclusion of our inspections on December 18, 2023, and February 9, 2024, you were issued two separate Forms FDA 483, Inspectional Observations. We received your written responses to these observations dated January 10, 2024, March 4, 2024, and July 10, 2024, and address your corrective actions below, in relation to each of the noted violations.
Hazard Analysis and Risk-Based Preventive Controls Requirements
Your animal food facility is subject to the hazard analysis and risk-based preventive controls requirements found in 21 CFR Part 507, subparts A, C, D, E, and F. During the inspection of your facility, the FDA Investigators obtained evidence of significant violations of these requirements, which included:
1. You did not identify and implement a preventive control to provide assurances that any hazards requiring a preventive control will be significantly minimized or prevented, as required by 21 CFR 507.34(a)(1).
Specifically, your hazard analysis determined the hazard of Salmonella requires preventive controls and identified sanitation and process controls to control the hazard of Salmonella in your finished pet food.
A. Your Food Safety Plan dated January 9, 2024, documents your sanitation control for Salmonella spp. in post-extrusion processing environments by removing residual material on post-extruder surfaces and applying sanitizer in accordance with the sanitizer label. However, you failed to adequately implement your sanitation control.
i. You use (b)(4) as a sanitizer for food-contact equipment and utensils. Your “(b)(4) Procedure” (SOP 1500) standard operating procedure (SOP), dated December 5, 2023, documents, “Surfaces must remain thoroughly wetted for (b)(4) followed by adequate draining and air drying . . . [a]llow the identified surface to air dry before the manufacturing process can resume, or the identified surface is reintroduced for use.” Furthermore, the label for (b)(4) documents “treated surfaces must remain wet for at least (b)(4) followed by adequate draining and air drying” for food-processing equipment and food-contact surfaces. On January 30, 2024, FDA Investigators observed an employee designated to the post-extrusion area cleaning food-contact equipment who used (b)(4) to sanitize the equipment and then immediately dried the surface of the equipment with a paper towel. During this cleaning, the equipment made direct contact with the employee’s clothing which was visibly soiled with apparent dog food.
ii. Your “Housekeeping Procedure” (CGMP 2800),” dated February 2, 2022, documents that the sanitation lead employee write their initials on sanitation records to document their inspection and review of sanitation activities on the Master Cleaning Schedule. Your Master Cleaning Schedule, “Housekeeping #5” for December 2023 does not document (b)(4) cleaning for the discharge hoppers located in the packaging area for the entire month of December 2023.
In addition, there were multiple instances of other equipment and areas where you did not document sanitation activities in accordance with your Master Cleaning Schedule in April 2023, May 2023, June 2023, September 2023, December 2023, and January 2024.
iii. On January 26, 2024, FDA Investigators observed visible debris on food-contact surfaces of equipment such as brushes, brooms, and squeegees after cleaning and sanitizing of equipment was performed by your third-party sanitation service. In addition, you could not produce any sanitation records for July and August of 2023 and your records for April 2023 and May 2023 were incomplete. Your lack of complete records in addition to the ineffective cleaning observed by Investigators demonstrates your failure to implement your sanitation preventive control.
B. Your Food Safety Plan dated January 9, 2024, documents “CGMP controls” to minimize the hazard of Salmonella spp. in post-extrusion processing environments.
i. On January 23, 2024, FDA Investigators observed rainwater entering your facility through the roof while you were manufacturing multiple lots of dog food. FDA Investigators observed standing water and soaked absorbent pads in staging, production, and finished product areas, including in post-process areas such as the dryer room and packaging areas. Your manufacturing facility must be constructed in a manner such does not become a source of potential contamination to your animal food.
C. Your Food Safety Plan dated January 9, 2024, documents your process control for Salmonella spp. at the Storage of Liquid Bulk Ingredients step for chicken fat is to (b)(4) and (b)(4).
i. You did not document the (b)(4) process control applied to your chicken fat prior to January 13, 2024, which demonstrates you did not effectively implement your process control. Your (b)(4) Log (SOP-5800F-(b)(4)), documents that from January 13 through February 4, 2024, you did not routinely (b)(4) in accordance with the validation study you provided for this process. The target (b)(4) listed as a parameter in on the (b)(4) Log is (b)(4), and your records document that you (b)(4) to (b)(4) of (b)(4) truckloads of fat received from January 13 through February 4, 2024.
ii. You did not document that the (b)(4) process control of (b)(4) was applied to your chicken fat until January 29, 2024. You produced approximately (b)(4) pounds of Victor Brand Dog Food using this fat from January 13, 2024, to January 28, 2024.
Evaluation of your response:
A. Your response dated January 10, 2024, documents that you updated your Master Sanitation schedule, updated sanitation standard operating procedures, and provided training to your employees. In addition, your response provided a timeline of the steps you took in response to the recalls, which included hiring a consultant and voluntarily closing your facility in November 2023 to perform deep cleaning and implement corrections. However, you did not provide records that document your new sanitation programs are implemented and we were unable to evaluate your corrections. In addition, FDA Investigators observed sanitation deficiencies persisted through the January to February 2024 inspection. Your response dated March 4, 2024, stated, “our programs have been, and are, effective for controlling Salmonella contamination both in finished product, as well as within the facility.” However, sampling conducted by FDA Investigators and by your employees as part of your finished product and environmental testing indicates Salmonella continued to persist in your facility. For example, FDA Investigators found Salmonella in 40 of 100 environmental swabs taken November 2, 2023, of which 17 positive swabs were from the extrusion or post-extrusion areas. In addition, FDA Investigators collected additional environmental swabs from the extrusion and post-extrusion areas on January 25, 2024, three of which were positive for Salmonella and genetically related to seven swabs collected during FDA’s 2023 inspection. Finally, you provided copies of your updated Master Sanitation Schedule, sanitation standard operating procedures, training records, and limited sanitation records (December 22, 2023, and January 4 and 31, 2024) in your response dated March 4, 2024. We are unable to fully evaluate your corrections from these limited records and will verify the status of your corrections during the next inspection. We encourage you to provide us with documentation of implementation of your corrections in follow-up correspondence.
B. Your response dated July 10, 2024, provided invoices from a roofing company including roof repairs and installing a (b)(4). We will verify the status of these corrective actions during the next inspection.
C. Your response dated March 4, 2024, stated that since January 13, 2024, you have updated your procedure and now (b)(4) to each new truckload of chicken fat you receive. After (b)(4), you stated you (b)(4). You stated in your response that you are installing (b)(4) that will (b)(4), have retrained employees, and provided temperature monitoring documents during the FDA inspection. However, you did not demonstrate that your (b)(4) is appropriately calculated to (b)(4) required to achieve a (b)(4) reduction of Salmonella in accordance with the validation study you provided. The target concentration listed as a parameter in on the (b)(4) Log is (b)(4), and your records document that you (b)(4) to (b)(4) of (b)(4) truckloads of chicken fat received from January 13 through February 4, 2024. Therefore, we are unable to fully evaluate your corrections and will verify the status of your corrections during the next inspection. We encourage you to provide us with documentation of implementation of your corrections in follow-up correspondence.
2. You did not take appropriate corrective action when a preventive control, combination of preventive controls, or the food safety plan as a whole was found to be ineffective, as required by 21 CFR 507.42(b)(1)(ii), in order to identify and correct the problem, reduce the likelihood that the problem will recur, evaluate all affected animal food for safety, and when appropriate, reanalyze the food safety plan as required by 507.42(b)(2).
A. Specifically, your Food Safety Plan, dated January 9, 2024, documents your sanitation control for Salmonella spp. in post-extrusion processing environments requires environmental monitoring. Your “Environmental Monitoring Program,” (EMP) (SOP-3525), dated November 22, 2023, documents “[s]ince all finished products are tested using (b)(4) sampling and testing for Salmonella, the EMP will not include Zone (b)(4) pathogen testing. It is generally accepted that finished product pathogen testing substitute [sic] for Zone (b)(4) pathogen testing.” Seventeen of the finished product lots you collected between the dates of December 20, 2023, and January 29, 2024, were positive for Salmonella. Ten of these Salmonella-positive samples were collected after you ceased manufacturing to conduct intensive cleaning and sanitation operations from December 23 through 25, 2023. In addition, you collected one additional Salmonella-positive sample on January 29, 2024, after you ceased manufacturing to conduct intensive cleaning and sanitation operations from January 10, 2024, to January 12, 2024.
Finished product testing is the only verification procedure of effective implementation for the following of your preventive controls: (b)(4) process control, zone (b)(4) sanitation control, and extruder (b)(4) process control. You could not provide Investigators documentation demonstrating you conducted any root cause analyses to determine which of your preventive controls may have failed when samples from your finished product tested positive for Salmonella spp. Furthermore, you did not assess the food safety impact the affected finished product lots may have had on shared equipment prior to distributing subsequent lots made on the shared equipment in interstate commerce.
B. Your “Environmental Monitoring Program (EMP)” SOP, (SOP-3525), dated November 22, 2023, documents you will “assess the impact of the [Salmonella] positive on the finished products (for zone (b)(4) positives only)” and collect a minimum of (b)(4) “vector swabs” before and after sanitation, (b)(4) of which will be the original positive site. However, you failed to collect the required minimum (b)(4) “vector swabs” before and after sanitation (including the original Salmonella positive site), and assess the impact of Salmonella positive environmental positives on the finished product on the following occasions:
i. On December 21, 2023, you received Salmonella-positive environmental sampling results for sample “(b)(4)” from a swab you collected on December 17, 2023, from “(b)(4) Dryer Zone (b)(4) South west (b)(4) door.” Your environmental monitoring program SOP documents that you will collect a minimum of (b)(4) “vector swabs” before and after sanitation, (b)(4) of which will be the original positive site. However, you only collected (b)(4) “vector swabs”, none of which included the original positive site. In addition, you did not assess the food safety impact on any of the finished product lots you manufactured between December 17, 2023, and December 21, 2023, when you conducted cleaning and re-testing of the environment in accordance with your environmental monitoring program SOP. Products manufactured during this time were released to interstate commerce.
ii. On December 26, 2023, you received Salmonella-positive environmental sampling results for sample “(b)(4)” from a swab you collected on December 21, 2023, from the zone (b)(4) above (b)(4) leading to (b)(4) underneath (b)(4) equipment and repair sign on (b)(4) dryer.” Your environmental monitoring program SOP documents that you will collect a minimum (b)(4) “vector swabs” before and after sanitation, (b)(4) of which will be the original positive site. However, you only collected (b)(4) “vector swabs”, none of which included the original positive site. In addition, you did not assess the food safety impact on any of the finished product lots you manufactured between December 21, 2023, and December 23, 2023, after which you ceased operations through December 26, 2023. Products manufactured during this time were released to interstate commerce.
Evaluation of your response:
Your response dated March 4, 2024, stated that you believe your programs are effective for controlling Salmonella both in the manufacturing environment and in finished product. Additionally, you provided documentation of your sanitation activities for the dates following the Salmonella-positive environmental and product samples and stated that you have updated your procedures to require a root cause analysis for each positive event and would supplement your response with updated root cause analyses with an expected completion in four to eight weeks. Your response dated July 10, 2024, included copies of examples of your facility’s corrective actions when Salmonella is found through your environmental monitoring program. However, your root cause analysis does not consider how you will reduce the likelihood the problem will recur. Additionally, we cannot evaluate your investigation into possibly affected animal food due to illegible documents regarding product testing. Therefore, we are unable to fully evaluate your corrections and will verify the status of your corrections during the next inspection. We encourage you to provide us with documentation of implementation of your corrections in follow-up correspondence.
Conclusion
This letter is not intended to be an all-inclusive statement of violations that may exist at your facility or in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law and FDA regulations.
This letter notifies you of our concerns and provides you an opportunity to address them. You should take prompt action to correct the violations cited in this letter. Failure to adequately address this matter may lead to legal action, including, without limitation, seizure, and injunction.
For more information about FDA’s current thinking on the requirements of 21 CFR Part 507, see:
Guidance for Industry #235: “Current Good Manufacturing Practice Requirements for Food for Animals”, https://www.fda.gov/media/97464/download
Guidance for Industry #245: “Hazard Analysis and Risk-Based Preventive Controls for Food for Animals”, https://www.fda.gov/media/110477/download
Draft Guidance for Industry #246: “Hazard Analysis and Risk-Based Preventive Controls for Food for Animals: Supply Chain Program”, https://www.fda.gov/media/113923/download
Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps you have taken to correct any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration.
In the interest of administrative efficiency, fiscal responsibility, and environmental awareness, the Food & Drug Administration, Center for Veterinary Medicine, Office of Surveillance and Compliance is encouraging electronic submission of correspondence. In support of our efforts, we offer facilities the opportunity to submit all correspondence in electronic format up to 100 megabytes. Files greater than 100 megabytes may be submitted as smaller files in separate emails. There is no need to provide a back-up hard copy of any documentation you submit electronically. If you submit electronic correspondence, please ensure that the facility name, establishment identifier (FEI), and inspection location are included in the correspondence. An electronic acknowledgement will be issued upon receipt of your email. Please direct your electronic correspondence to CVMAnimalFoodCompliance@fda.hhs.gov and copy Compliance Officer Jessica Nanini (jessica.nanini@fda.hhs.gov). Including both email addresses will ensure your correspondence is routed as quickly as possible to the appropriate Agency personnel.
If you are unable to submit your correspondence electronically, please direct it to the attention of Compliance Officer Jessica D. Nanini at the following address:
United States Food & Drug Administration
Center for Veterinary Medicine
Office of Surveillance and Compliance
MPN 2, Room E436
12225 Wilkins Avenue
Rockville, Maryland 20852
If you have questions regarding this letter, please contact Compliance Officer Jessica D. Nanini by telephone at (443) 280-1276, or by email at jessica.nanini@fda.hhs.gov.
Sincerely,
/S/
Isaac K. Carney
Director, Division of Food Compliance
Office of Surveillance and Compliance
Center for Veterinary Medicine
Cc:
Mary Sasser, Program Director
Office of the Texas State Chemist
445 Agronomy Road
College Station, Texas 77843
Lorey Bell Grady, Feed Safety Program Manager
South Carolina Department of Agriculture
123 Ballard Court
West Columbia, South Carolina 29172
____________________
1 Centers for Disease Control and Prevention, Investigation Details Salmonella Outbreak Linked to Dry Dog Food, https://www.cdc.gov/salmonella/outbreaks/dog-food-10-23/investigation.html
2 See section 402(a)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) [21 U.S.C. § 342(a)(1)].
3 See section 402(a)(4) of the FD&C Act [21 U.S.C. § 342(a)(4)] and 21 CFR 507.1(a)(1)(ii).
4 See section 301(a) of the FD&C Act [21 U.S.C. § 331(a)].
5 See section 301(uu) of the FD&C Act [21 U.S.C. § 331(uu)].
Evaluation of your response:
A. Your response dated January 10, 2024, documents that you updated your Master Sanitation schedule, updated sanitation standard operating procedures, and provided training to your employees. In addition, your response provided a timeline of the steps you took in response to the recalls, which included hiring a consultant and voluntarily closing your facility in November 2023 to perform deep cleaning and implement corrections. However, you did not provide records that document your new sanitation programs are implemented and we were unable to evaluate your corrections. In addition, FDA Investigators observed sanitation deficiencies persisted through the January to February 2024 inspection. Your response dated March 4, 2024, stated, “our programs have been, and are, effective for controlling Salmonella contamination both in finished product, as well as within the facility.” However, sampling conducted by FDA Investigators and by your employees as part of your finished product and environmental testing indicates Salmonella continued to persist in your facility. For example, FDA Investigators found Salmonella in 40 of 100 environmental swabs taken November 2, 2023, of which 17 positive swabs were from the extrusion or post-extrusion areas. In addition, FDA Investigators collected additional environmental swabs from the extrusion and post-extrusion areas on January 25, 2024, three of which were positive for Salmonella and genetically related to seven swabs collected during FDA’s 2023 inspection. Finally, you provided copies of your updated Master Sanitation Schedule, sanitation standard operating procedures, training records, and limited sanitation records (December 22, 2023, and January 4 and 31, 2024) in your response dated March 4, 2024. We are unable to fully evaluate your corrections from these limited records and will verify the status of your corrections during the next inspection. We encourage you to provide us with documentation of implementation of your corrections in follow-up correspondence.
B. Your response dated July 10, 2024, provided invoices from a roofing company including roof repairs and installing a (b)(4). We will verify the status of these corrective actions during the next inspection.
C. Your response dated March 4, 2024, stated that since January 13, 2024, you have updated your procedure and now (b)(4) to each new truckload of chicken fat you receive. After (b)(4), you stated you (b)(4). You stated in your response that you are installing (b)(4) that will (b)(4), have retrained employees, and provided temperature monitoring documents during the FDA inspection. However, you did not demonstrate that your (b)(4) is appropriately calculated to (b)(4) required to achieve a (b)(4) reduction of Salmonella in accordance with the validation study you provided. The target concentration listed as a parameter in on the (b)(4) Log is (b)(4), and your records document that you (b)(4) to (b)(4) of (b)(4) truckloads of chicken fat received from January 13 through February 4, 2024. Therefore, we are unable to fully evaluate your corrections and will verify the status of your corrections during the next inspection. We encourage you to provide us with documentation of implementation of your corrections in follow-up correspondence.
2. You did not take appropriate corrective action when a preventive control, combination of preventive controls, or the food safety plan as a whole was found to be ineffective, as required by 21 CFR 507.42(b)(1)(ii), in order to identify and correct the problem, reduce the likelihood that the problem will recur, evaluate all affected animal food for safety, and when appropriate, reanalyze the food safety plan as required by 507.42(b)(2).
A. Specifically, your Food Safety Plan, dated January 9, 2024, documents your sanitation control for Salmonella spp. in post-extrusion processing environments requires environmental monitoring. Your “Environmental Monitoring Program,” (EMP) (SOP-3525), dated November 22, 2023, documents “[s]ince all finished products are tested using (b)(4) sampling and testing for Salmonella, the EMP will not include Zone (b)(4) pathogen testing. It is generally accepted that finished product pathogen testing substitute [sic] for Zone (b)(4) pathogen testing.” Seventeen of the finished product lots you collected between the dates of December 20, 2023, and January 29, 2024, were positive for Salmonella. Ten of these Salmonella-positive samples were collected after you ceased manufacturing to conduct intensive cleaning and sanitation operations from December 23 through 25, 2023. In addition, you collected one additional Salmonella-positive sample on January 29, 2024, after you ceased manufacturing to conduct intensive cleaning and sanitation operations from January 10, 2024, to January 12, 2024.
Finished product testing is the only verification procedure of effective implementation for the following of your preventive controls: (b)(4) process control, zone (b)(4) sanitation control, and extruder (b)(4) process control. You could not provide Investigators documentation demonstrating you conducted any root cause analyses to determine which of your preventive controls may have failed when samples from your finished product tested positive for Salmonella spp. Furthermore, you did not assess the food safety impact the affected finished product lots may have had on shared equipment prior to distributing subsequent lots made on the shared equipment in interstate commerce.
B. Your “Environmental Monitoring Program (EMP)” SOP, (SOP-3525), dated November 22, 2023, documents you will “assess the impact of the [Salmonella] positive on the finished products (for zone (b)(4) positives only)” and collect a minimum of (b)(4) “vector swabs” before and after sanitation, (b)(4) of which will be the original positive site. However, you failed to collect the required minimum (b)(4) “vector swabs” before and after sanitation (including the original Salmonella positive site), and assess the impact of Salmonella positive environmental positives on the finished product on the following occasions:
i. On December 21, 2023, you received Salmonella-positive environmental sampling results for sample “(b)(4)” from a swab you collected on December 17, 2023, from “(b)(4) Dryer Zone (b)(4) South west (b)(4) door.” Your environmental monitoring program SOP documents that you will collect a minimum of (b)(4) “vector swabs” before and after sanitation, (b)(4) of which will be the original positive site. However, you only collected (b)(4) “vector swabs”, none of which included the original positive site. In addition, you did not assess the food safety impact on any of the finished product lots you manufactured between December 17, 2023, and December 21, 2023, when you conducted cleaning and re-testing of the environment in accordance with your environmental monitoring program SOP. Products manufactured during this time were released to interstate commerce.
ii. On December 26, 2023, you received Salmonella-positive environmental sampling results for sample “(b)(4)” from a swab you collected on December 21, 2023, from the zone (b)(4) above (b)(4) leading to (b)(4) underneath (b)(4) equipment and repair sign on (b)(4) dryer.” Your environmental monitoring program SOP documents that you will collect a minimum (b)(4) “vector swabs” before and after sanitation, (b)(4) of which will be the original positive site. However, you only collected (b)(4) “vector swabs”, none of which included the original positive site. In addition, you did not assess the food safety impact on any of the finished product lots you manufactured between December 21, 2023, and December 23, 2023, after which you ceased operations through December 26, 2023. Products manufactured during this time were released to interstate commerce.
Evaluation of your response:
Your response dated March 4, 2024, stated that you believe your programs are effective for controlling Salmonella both in the manufacturing environment and in finished product. Additionally, you provided documentation of your sanitation activities for the dates following the Salmonella-positive environmental and product samples and stated that you have updated your procedures to require a root cause analysis for each positive event and would supplement your response with updated root cause analyses with an expected completion in four to eight weeks. Your response dated July 10, 2024, included copies of examples of your facility’s corrective actions when Salmonella is found through your environmental monitoring program. However, your root cause analysis does not consider how you will reduce the likelihood the problem will recur. Additionally, we cannot evaluate your investigation into possibly affected animal food due to illegible documents regarding product testing. Therefore, we are unable to fully evaluate your corrections and will verify the status of your corrections during the next inspection. We encourage you to provide us with documentation of implementation of your corrections in follow-up correspondence.
Conclusion
This letter is not intended to be an all-inclusive statement of violations that may exist at your facility or in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law and FDA regulations.
This letter notifies you of our concerns and provides you an opportunity to address them. You should take prompt action to correct the violations cited in this letter. Failure to adequately address this matter may lead to legal action, including, without limitation, seizure, and injunction.
For more information about FDA’s current thinking on the requirements of 21 CFR Part 507, see:
Guidance for Industry #235: “Current Good Manufacturing Practice Requirements for Food for Animals”, https://www.fda.gov/media/97464/download
Guidance for Industry #245: “Hazard Analysis and Risk-Based Preventive Controls for Food for Animals”, https://www.fda.gov/media/110477/download
Draft Guidance for Industry #246: “Hazard Analysis and Risk-Based Preventive Controls for Food for Animals: Supply Chain Program”, https://www.fda.gov/media/113923/download
Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps you have taken to correct any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration.
In the interest of administrative efficiency, fiscal responsibility, and environmental awareness, the Food & Drug Administration, Center for Veterinary Medicine, Office of Surveillance and Compliance is encouraging electronic submission of correspondence. In support of our efforts, we offer facilities the opportunity to submit all correspondence in electronic format up to 100 megabytes. Files greater than 100 megabytes may be submitted as smaller files in separate emails. There is no need to provide a back-up hard copy of any documentation you submit electronically. If you submit electronic correspondence, please ensure that the facility name, establishment identifier (FEI), and inspection location are included in the correspondence. An electronic acknowledgement will be issued upon receipt of your email. Please direct your electronic correspondence to CVMAnimalFoodCompliance@fda.hhs.gov and copy Compliance Officer Jessica Nanini (jessica.nanini@fda.hhs.gov). Including both email addresses will ensure your correspondence is routed as quickly as possible to the appropriate Agency personnel.
If you are unable to submit your correspondence electronically, please direct it to the attention of Compliance Officer Jessica D. Nanini at the following address:
United States Food & Drug Administration
Center for Veterinary Medicine
Office of Surveillance and Compliance
MPN 2, Room E436
12225 Wilkins Avenue
Rockville, Maryland 20852
If you have questions regarding this letter, please contact Compliance Officer Jessica D. Nanini by telephone at (443) 280-1276, or by email at jessica.nanini@fda.hhs.gov.
Sincerely,
/S/
Isaac K. Carney
Director, Division of Food Compliance
Office of Surveillance and Compliance
Center for Veterinary Medicine
Cc:
Mary Sasser, Program Director
Office of the Texas State Chemist
445 Agronomy Road
College Station, Texas 77843
Lorey Bell Grady, Feed Safety Program Manager
South Carolina Department of Agriculture
123 Ballard Court
West Columbia, South Carolina 29172
____________________
1 Centers for Disease Control and Prevention, Investigation Details Salmonella Outbreak Linked to Dry Dog Food, https://www.cdc.gov/salmonella/outbreaks/dog-food-10-23/investigation.html
2 See section 402(a)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) [21 U.S.C. § 342(a)(1)].
3 See section 402(a)(4) of the FD&C Act [21 U.S.C. § 342(a)(4)] and 21 CFR 507.1(a)(1)(ii).
4 See section 301(a) of the FD&C Act [21 U.S.C. § 331(a)].
5 See section 301(uu) of the FD&C Act [21 U.S.C. § 331(uu)].
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