The supply-chain program does not provide assurance that a hazard requiring a supply-chain-applied control has been significantly minimized or prevented, as required per 21 CFR 117.410(c).
- The company receives untreated herbs, spices, dried fruits and peels, and dried vegetable products and then directs the untreated products to (b)(4) third-party providers that apply a lethality process.
- The "preventive control measure is “Validated lethality ‘kill step’ with Treatment Certificate”, however, the company's supply chain program does not verify that the parameters selected and applied by 3rd party treatment providers are adequate to control the hazard of vegetative pathogens such as Salmonella.
- There is no review of the process parameters identified in the treatment certificate from the (b)(4) providers, as identified as a preventive control measure required within Hazard Analysis, and you
- Did not comprehensively evaluate whether the parameters are appropriate for all your products undergoing the treatment.
- Did not maintain documentation that the untreated spices you purchase and send to the third-party (b)(4) providers are treated under a validated process that delivers an appropriate destruction of Salmonella.
The company did not conduct a reanalysis of your food safety plan when needed after Ground Organic Parsley, lot # 62868 and lot # 63196, tested positive for the pesticide Chlorpyrifos ((b)(4)).
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/high-quality-organics-inc-677503-07082024
WARNING LETTER
High Quality Organics, Inc.
MARCS-CMS 677503 — July 08, 2024
Recipient:
Mr. Boligala C. Raju
Chief Executive Officer
High Quality Organics, Inc.
12101 Moya Blvd.
Reno, NV 89506-2600
United States
Issuing Office:
Division of Human and Animal Food Operations West V
United States
WARNING LETTER
July 8, 2024
WL CMS# 677503
Dear Mr. Raju:
The United States Food and Drug Administration (FDA) inspected your ready-to-eat (RTE) spice facility, located at 12101 Moya Blvd., Reno, NV, from November 27 through December 07, 2023, and January 03 through January 04, 2024. The inspection covered processing and/or packaging of RTE organic herbs, spices, dried fruit and peels, and dried vegetables. During our inspection, FDA 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).
Based on FDA’s inspectional findings, we have determined that the RTE herbs, spices, dried fruit and peels, and dried vegetables processed and/or packaged 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 have been prepared, packed or held under insanitary conditions whereby they may have become 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)]. You may find the Act and further information about the CGMP & PC rule through links on FDA’s homepage at www.fda.gov.
At the conclusion of the inspection, FDA investigators issued a Form FDA 483 (FDA-483), Inspectional Observations. You provided a written response to the inspectional findings on January 25, 2024, describing corrective actions taken by your firm. After reviewing the inspectional findings and response that your firm provided, we are issuing this letter to advise you of FDA’s concerns and provide detailed information describing the findings at your facility. We also address your response below.
Your significant violations are as follows:
Supply-Chain Program (21 CFR Part 117, Subpart G)
1. You did not implement a risk-based supply-chain program for those raw materials and ingredients for which you have identified a hazard requiring a supply-chain-applied control, as required per 21 CFR 117.405(a)(1). Specifically, your written supply-chain program does not provide assurance that a hazard requiring a supply-chain-applied control has been significantly minimized or prevented, as required per 21 CFR 117.410(c). You receive untreated herbs, spices, dried fruits and peels, and dried vegetable products. You direct the untreated products to (b)(4) third-party providers that apply (b)(4). You stated during the inspection that you manage your third-party (b)(4) providers through your supply-chain program, and you expect (b)(4) providers to treat your products with validated parameters that will provide a (b)(4) reduction for Salmonella. Per your Hazard Analysis & Preventive Controls Determination record at step “(b)(4),” the preventive control measure is “Validated lethality ‘kill step’ with Treatment Certificate”. However, your supply-chain program does not verify that the parameters selected and applied by your (b)(4) providers are adequate to control the hazard of vegetative pathogens such as Salmonella. You do not review the process parameters identified in the treatment certificate from the (b)(4) providers, as identified as a preventive control measure required by your Hazard Analysis, and you have not comprehensively evaluated whether the parameters are appropriate for all your products undergoing the treatment. You do not maintain documentation that the untreated spices you purchase and send to the third-party (b)(4) providers are treated under a validated process that delivers an appropriate destruction of Salmonella.
As examples:
a. On March 30, 2023, you sent (b)(4) of Organic Caraway Seeds to (b)(4) for treatment. You received a (b)(4) Certificate dated April 7, 2023, that stated the caraway seeds were processed at a temperature of (b)(4) and “[t]he temperature was held for the duration at the core of the product.” You have not verified that this (b)(4) has been validated to provide an appropriate logarithmic reduction for pathogens such as Salmonella. The third-party audit report for (b)(4) stated, “treatment validations will occur upon request of the customer”. You have not requested a validation study to support the process parameters listed on the caraway seeds (b)(4) certificate. Specifically, during the inspection you told our investigator that you have not reviewed validation studies, as they are proprietary to the (b)(4) providers, and you do not maintain documentation that assures the (b)(4) process delivers a (b)(4) reduction. The third-party audit report also stated (under review of the Food Safety Plan at the (b)(4) step), “No pathogens were identified since this is just a customer treatment (toll processing) with no validation [by HQO]. This is disclosed to service customers vis contracts or WO.” The caraway seeds at issue were used in the processing of O Montreal a.k.a. Nebbraska Stk, lot # 65443. You have four validation studies conducted prior to 2017 for black peppercorn, sliced ginger, parsley and crushed red pepper – all of which listed critical parameters with higher time and/or temperatures than what is listed on the (b)(4) certificate.
In your written response, you stated that (b)(4) is working with their technical department to determine the best way to address this concern. However, your response did not demonstrate that all products sent to third-party (b)(4) providers will be treated with appropriate parameters to control Salmonella. You did not include a revised procedure for your supply-chain program or revised implementation records. You did not indicate that you will ensure the provider validated its treatment, you will review this validation information, or you will verify the validation appropriately applies to each type of product sent to this provider.
Also, you have previously promised to take corrective actions. At the conclusion of the FDA 2020 inspection, an FDA-483 was issued to you on December 4, 2020, for failure to identify a preventive control for pathogens in your RTE dried herbs and spices and for the (b)(4) raw materials which you sent to a third-party (b)(4) facility; you did not verify that validated (b)(4) processes were in place. You stated in your response, dated December 24, 2020, that all products would be treated with a validated lethality process by either your supplier or contracted third-party facility. You also stated, “Documentation on the validated lethality treatment must be reviewed by HQO prior to shipment of product to ensure that the supplier has a validated lethality treatment for the particular product and size/shape that is to be shipped for treatment.” This review was not conducted.
b. On September 6, 2023, you sent (b)(4) of dried Organic Lemon Peel to (b)(4) for treatment. You received a certificate of treatment that same day that stated the “Minimum Temperature & Dwell Time: (b)(4).” The third-party audit report for (b)(4) stated the critical limit for the treatment is (b)(4)”, but product and customer specific. You did not verify that this (b)(4) has been validated to provide an appropriate logarithmic reduction for pathogens such as Salmonella or how it is applicable to each type of product you send for treatment. During the inspection, you told our investigator that you have not reviewed validation studies, as they are proprietary to the (b)(4) providers, and that you do not maintain documentation that assures the (b)(4) process delivers a (b)(4) reduction. The lemon peel was used in the manufacturing of Organic No Salt Blend, lot # 65724.
In your written response, you stated that (b)(4) revised the language on its treatment certificate to include the statement: “The treatment process follow [sic] our ’(b)(4)’ by subjecting the product to our (b)(4) of pathogens (Salmonella) that follow specific treatment parameters which are product specific.” However, your response did not demonstrate that all products will be treated with appropriate parameters to control Salmonella. You did not indicate that you will review the validation information relied on by the provider to ensure the treatment is adequate. You did not indicate that you will verify the validation appropriately applies to each type of product sent to this provider.
Also, your written supply chain program procedure entitled “VENDOR MANAGEMENT PROGRAM, Revision Date: 06/12/2023” states, under “Vendor Monitoring”, “(b)(4).” Per the procedure, “(b)(4)” to assist with ongoing monitoring to ensure vendor compliance. On December 4, 2023, our investigator requested to review the (b)(4) for (b)(4) of your suppliers who provided raw materials used in the manufacturing of No Salt Blend. You were unable to provide a (b)(4) for one of the suppliers. Furthermore, you indicated that you stopped completing (b)(4) for all your suppliers after June 2021 despite still receiving raw materials from some suppliers since that date. Also, (b)(4) completed up until then and reviewed during the inspection were incomplete to ensure adequate supply-chain control. For example, the supplier (b)(4) for (b)(4) (which supplied Organic Vegmix containing carrot, garlic, onion, red bell pepper, and tomato granules) and (b)(4) (which supplied organic cumin) dated June 4, 2021 were incomplete in that you did not record what valid documents you had on file, what documents were missing (e.g., current third-party audit results or validation studies), and what requests were pending. These ingredients were used in the processing of No Salt Blend, lot # 65724.
You explained in your written response that the existing (b)(4) system for documenting supplier reviews was not maintained due to employee attrition and the realignment of resources. Further, you stated a more sustainable revised system to document supplier compliance and performance in your supply-chain is being developed and it will be utilized (b)(4) in your decision process to maintain or discontinue approval of a supplier. However, you have previously promised to take corrective actions. At the conclusion of the FDA 2021 inspection, the FDA-483 dated September 17, 2021, included an observation that you did not conduct and document appropriate supplier verification activities such as onsite audits for the control of the pathogen and recontamination with environmental pathogens hazards through the supply-chain. (b)(4) was (b)(4) suppliers given as an example for this observation. Further, it was noted in the 2021 inspection report that you did not have complete supplier documentation per the Vendor Management Program in place at the time for (b)(4). In your response received on October 8, 2021, you explained you developed a scorecard system and began a pilot program in April 2021 which you expanded to include all suppliers in October 2021. Further, you promised to implement and maintain this “(b)(4)” system to ensure maintenance of required records. Your response did not include evidence to demonstrate the system had been implemented per your description of its capabilities. We are concerned that your (b)(4) system may not be attainable as you failed to provide evidence or explanation of how it will be different from your previous (b)(4) system developed in response to the 2021 Inspection.
Hazard Analysis and Risk-Based Preventive Controls (21 CFR Part 117, Subpart C)
2. You did not conduct a reanalysis of your food safety plan when needed, as required by 21 CFR 117.170. You must conduct a reanalysis of the food safety plan as a whole, or the applicable portion of the food safety plan, whenever you became aware of new information about potential hazards associated with the food, as required per 21 CFR 117.170(b)(2). Specifically, on April 28, 2023, you became aware of new information when you received a complaint from your customer that Ground Organic Parsley, lot # 62868 and lot # 63196, tested positive for the pesticide Chlorpyrifos ((b)(4)). There is no tolerance for Chlorpyrifos in parsley; therefore, the parsley lots are adulterated within the meaning of section 402(a)(2)(B) of the Act [21 U.S.C. § 342(a)(2)(B)], in that they bear or contain a pesticide chemical residue that is unsafe within the meaning of section 408(a) of the Act [21 U.S.C. § 346 (a)].
During the inspection, our investigator discussed with you that pesticides was not identified in your hazard analysis as a hazard requiring a supply-chain control. Your hazard analysis includes a justification of “only using organic suppliers with (b)(4) crop testing for pesticides”. Considering the complaint from April 2023, a reanalysis of the pesticide hazard is warranted to consider whether pesticides are a hazard requiring a supply-chain-applied control.
In your written response you included a statement, in relation to unidentified hazards, that your Food Safety Team will review your current Food Safety Plan and make necessary changes. However, you did not provide evidence of review and revision or a timeframe for review and revision of your Food Safety Plan.
The violations cited in this letter are not intended to be an all-inclusive list 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 your firm complies with all requirements of federal law, including FDA regulations.
This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action including, without limitation, seizure, injunction, or administrative action for suspension of food facility registration if criteria and conditions warrant.
We also offer the following comment:
We note that in your supply-chain procedure “VENDOR MANAGEMENT PROGRAM Revision Date: 06/12/2023”, as a “Minimum Requirement for All Approved Vendors”, you identified a supplier verification activity of an (b)(4) onsite audit for GMPs and food safety. Furthermore, you stated that copies of third-party audit results are reviewed for passing score, corrective actions to observations, processing procedures, sanitation, traffic flow, GMP programs, and environmental monitoring. However, your written response acknowledged that you do not consistently document your review of third-party audit results. For the supplier verification activity of an onsite audit, you must review the audit results and document that review in order to ensure supply-chain-applied control.
Please notify FDA in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to address 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 actions within 15 working days, state the reason for the delay and the time within which you will do so. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration.
Your written response to this letter should be sent to:
Sergio Chavez, Director, Compliance Branch
Food and Drug Administration
Office of Human and Animal Foods Division West 5
1201 Harbor Bay Parkway
Alameda, CA 94502
Refer to Unique Identification Number CMS# 677503 when replying.
If you prefer to send your response electronically, please email it to ORAHAFWEST5FirmResponses@fda.hhs.gov. Please include the name of your firm and the Unique Identification number in the title of the e-mail message.
If you have any questions regarding this letter, please contact Kimberly M. Lichter, Compliance Officer, at kimberly.lichter@fda.hhs.gov or (949) 608-2967.
Sincerely,
/S/
Darla R. Bracy
Program Division Director
Office of Human and Animal Food Operations – West Division 5
a. On March 30, 2023, you sent (b)(4) of Organic Caraway Seeds to (b)(4) for treatment. You received a (b)(4) Certificate dated April 7, 2023, that stated the caraway seeds were processed at a temperature of (b)(4) and “[t]he temperature was held for the duration at the core of the product.” You have not verified that this (b)(4) has been validated to provide an appropriate logarithmic reduction for pathogens such as Salmonella. The third-party audit report for (b)(4) stated, “treatment validations will occur upon request of the customer”. You have not requested a validation study to support the process parameters listed on the caraway seeds (b)(4) certificate. Specifically, during the inspection you told our investigator that you have not reviewed validation studies, as they are proprietary to the (b)(4) providers, and you do not maintain documentation that assures the (b)(4) process delivers a (b)(4) reduction. The third-party audit report also stated (under review of the Food Safety Plan at the (b)(4) step), “No pathogens were identified since this is just a customer treatment (toll processing) with no validation [by HQO]. This is disclosed to service customers vis contracts or WO.” The caraway seeds at issue were used in the processing of O Montreal a.k.a. Nebbraska Stk, lot # 65443. You have four validation studies conducted prior to 2017 for black peppercorn, sliced ginger, parsley and crushed red pepper – all of which listed critical parameters with higher time and/or temperatures than what is listed on the (b)(4) certificate.
In your written response, you stated that (b)(4) is working with their technical department to determine the best way to address this concern. However, your response did not demonstrate that all products sent to third-party (b)(4) providers will be treated with appropriate parameters to control Salmonella. You did not include a revised procedure for your supply-chain program or revised implementation records. You did not indicate that you will ensure the provider validated its treatment, you will review this validation information, or you will verify the validation appropriately applies to each type of product sent to this provider.
Also, you have previously promised to take corrective actions. At the conclusion of the FDA 2020 inspection, an FDA-483 was issued to you on December 4, 2020, for failure to identify a preventive control for pathogens in your RTE dried herbs and spices and for the (b)(4) raw materials which you sent to a third-party (b)(4) facility; you did not verify that validated (b)(4) processes were in place. You stated in your response, dated December 24, 2020, that all products would be treated with a validated lethality process by either your supplier or contracted third-party facility. You also stated, “Documentation on the validated lethality treatment must be reviewed by HQO prior to shipment of product to ensure that the supplier has a validated lethality treatment for the particular product and size/shape that is to be shipped for treatment.” This review was not conducted.
b. On September 6, 2023, you sent (b)(4) of dried Organic Lemon Peel to (b)(4) for treatment. You received a certificate of treatment that same day that stated the “Minimum Temperature & Dwell Time: (b)(4).” The third-party audit report for (b)(4) stated the critical limit for the treatment is (b)(4)”, but product and customer specific. You did not verify that this (b)(4) has been validated to provide an appropriate logarithmic reduction for pathogens such as Salmonella or how it is applicable to each type of product you send for treatment. During the inspection, you told our investigator that you have not reviewed validation studies, as they are proprietary to the (b)(4) providers, and that you do not maintain documentation that assures the (b)(4) process delivers a (b)(4) reduction. The lemon peel was used in the manufacturing of Organic No Salt Blend, lot # 65724.
In your written response, you stated that (b)(4) revised the language on its treatment certificate to include the statement: “The treatment process follow [sic] our ’(b)(4)’ by subjecting the product to our (b)(4) of pathogens (Salmonella) that follow specific treatment parameters which are product specific.” However, your response did not demonstrate that all products will be treated with appropriate parameters to control Salmonella. You did not indicate that you will review the validation information relied on by the provider to ensure the treatment is adequate. You did not indicate that you will verify the validation appropriately applies to each type of product sent to this provider.
Also, your written supply chain program procedure entitled “VENDOR MANAGEMENT PROGRAM, Revision Date: 06/12/2023” states, under “Vendor Monitoring”, “(b)(4).” Per the procedure, “(b)(4)” to assist with ongoing monitoring to ensure vendor compliance. On December 4, 2023, our investigator requested to review the (b)(4) for (b)(4) of your suppliers who provided raw materials used in the manufacturing of No Salt Blend. You were unable to provide a (b)(4) for one of the suppliers. Furthermore, you indicated that you stopped completing (b)(4) for all your suppliers after June 2021 despite still receiving raw materials from some suppliers since that date. Also, (b)(4) completed up until then and reviewed during the inspection were incomplete to ensure adequate supply-chain control. For example, the supplier (b)(4) for (b)(4) (which supplied Organic Vegmix containing carrot, garlic, onion, red bell pepper, and tomato granules) and (b)(4) (which supplied organic cumin) dated June 4, 2021 were incomplete in that you did not record what valid documents you had on file, what documents were missing (e.g., current third-party audit results or validation studies), and what requests were pending. These ingredients were used in the processing of No Salt Blend, lot # 65724.
You explained in your written response that the existing (b)(4) system for documenting supplier reviews was not maintained due to employee attrition and the realignment of resources. Further, you stated a more sustainable revised system to document supplier compliance and performance in your supply-chain is being developed and it will be utilized (b)(4) in your decision process to maintain or discontinue approval of a supplier. However, you have previously promised to take corrective actions. At the conclusion of the FDA 2021 inspection, the FDA-483 dated September 17, 2021, included an observation that you did not conduct and document appropriate supplier verification activities such as onsite audits for the control of the pathogen and recontamination with environmental pathogens hazards through the supply-chain. (b)(4) was (b)(4) suppliers given as an example for this observation. Further, it was noted in the 2021 inspection report that you did not have complete supplier documentation per the Vendor Management Program in place at the time for (b)(4). In your response received on October 8, 2021, you explained you developed a scorecard system and began a pilot program in April 2021 which you expanded to include all suppliers in October 2021. Further, you promised to implement and maintain this “(b)(4)” system to ensure maintenance of required records. Your response did not include evidence to demonstrate the system had been implemented per your description of its capabilities. We are concerned that your (b)(4) system may not be attainable as you failed to provide evidence or explanation of how it will be different from your previous (b)(4) system developed in response to the 2021 Inspection.
Hazard Analysis and Risk-Based Preventive Controls (21 CFR Part 117, Subpart C)
2. You did not conduct a reanalysis of your food safety plan when needed, as required by 21 CFR 117.170. You must conduct a reanalysis of the food safety plan as a whole, or the applicable portion of the food safety plan, whenever you became aware of new information about potential hazards associated with the food, as required per 21 CFR 117.170(b)(2). Specifically, on April 28, 2023, you became aware of new information when you received a complaint from your customer that Ground Organic Parsley, lot # 62868 and lot # 63196, tested positive for the pesticide Chlorpyrifos ((b)(4)). There is no tolerance for Chlorpyrifos in parsley; therefore, the parsley lots are adulterated within the meaning of section 402(a)(2)(B) of the Act [21 U.S.C. § 342(a)(2)(B)], in that they bear or contain a pesticide chemical residue that is unsafe within the meaning of section 408(a) of the Act [21 U.S.C. § 346 (a)].
During the inspection, our investigator discussed with you that pesticides was not identified in your hazard analysis as a hazard requiring a supply-chain control. Your hazard analysis includes a justification of “only using organic suppliers with (b)(4) crop testing for pesticides”. Considering the complaint from April 2023, a reanalysis of the pesticide hazard is warranted to consider whether pesticides are a hazard requiring a supply-chain-applied control.
In your written response you included a statement, in relation to unidentified hazards, that your Food Safety Team will review your current Food Safety Plan and make necessary changes. However, you did not provide evidence of review and revision or a timeframe for review and revision of your Food Safety Plan.
The violations cited in this letter are not intended to be an all-inclusive list 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 your firm complies with all requirements of federal law, including FDA regulations.
This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action including, without limitation, seizure, injunction, or administrative action for suspension of food facility registration if criteria and conditions warrant.
We also offer the following comment:
We note that in your supply-chain procedure “VENDOR MANAGEMENT PROGRAM Revision Date: 06/12/2023”, as a “Minimum Requirement for All Approved Vendors”, you identified a supplier verification activity of an (b)(4) onsite audit for GMPs and food safety. Furthermore, you stated that copies of third-party audit results are reviewed for passing score, corrective actions to observations, processing procedures, sanitation, traffic flow, GMP programs, and environmental monitoring. However, your written response acknowledged that you do not consistently document your review of third-party audit results. For the supplier verification activity of an onsite audit, you must review the audit results and document that review in order to ensure supply-chain-applied control.
Please notify FDA in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to address 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 actions within 15 working days, state the reason for the delay and the time within which you will do so. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration.
Your written response to this letter should be sent to:
Sergio Chavez, Director, Compliance Branch
Food and Drug Administration
Office of Human and Animal Foods Division West 5
1201 Harbor Bay Parkway
Alameda, CA 94502
Refer to Unique Identification Number CMS# 677503 when replying.
If you prefer to send your response electronically, please email it to ORAHAFWEST5FirmResponses@fda.hhs.gov. Please include the name of your firm and the Unique Identification number in the title of the e-mail message.
If you have any questions regarding this letter, please contact Kimberly M. Lichter, Compliance Officer, at kimberly.lichter@fda.hhs.gov or (949) 608-2967.
Sincerely,
/S/
Darla R. Bracy
Program Division Director
Office of Human and Animal Food Operations – West Division 5
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