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WARNING LETTER

Agroson’s LLC MARCS-CMS 620490 —


Delivery Method:
VIA EMAIL AND UNITED PARCEL SERVICE
Product:
Food & Beverages

Recipient:
Recipient Name
Ms. Maria Suarez
Recipient Title
Owner
Agroson’s LLC

735 Drake Street
Bronx, NY 10474-6115
United States

Issuing Office:
Division of Northeast Imports

United States


WARNING LETTER

March 11, 2022

Re: CMS # 620490

Dear Ms. Suarez:

On August 20, 2021 through September 3, 2021, the Food and Drug Administration (FDA) conducted a Foreign Supplier Verification Program (FSVP) inspection of Agroson’s LLC, located at 735 Drake Street, Bronx, NY 10474-6115. We also conducted inspections on August 12, 2019 and January 29, 2021 through February 16, 2021. These inspections were conducted to determine compliance with the requirements of section 805 of the Federal Food, Drug and Cosmetic Act (FD&C Act) (21 U.S.C. 384a) and the implementing FSVP regulation in 21 CFR part 1 subpart L.

The FSVP regulation requires that importers perform certain risk-based activities to verify that human and/or animal food they import into the United States has been produced in a manner that meets applicable U.S. food safety standards. You may find information relating to the FSVP regulation and your responsibilities to comply with the regulation through links in FDA’s FSVP web page at https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-final-rule-foreign-supplier-verification-programs-fsvp-importers-food-humans-and-animals.

During the most recent inspection, we found that you are not in compliance with the requirements of 21 CFR part 1, subpart L for the following foods you import: papayas and limes imported from (b)(4); papayas imported from (b)(4); and limes imported from (b)(4). Because of these significant violations, you are not in compliance with section 805 of the FD&C Act. We note that you stated during the inspection that your firm is (b)(4), though you may (b)(4) at some point in the future.

At the conclusion of the FSVP inspection conducted August 20, 2021, through September 3, 2021, our investigator provided you with a Form FDA 483a, FSVP Observations. To date, we have not received your response to the Form FDA 483a issued during the follow-up inspection.

Your significant violations of the FSVP regulation are as follows:

1. You did not develop, maintain, and follow an FSVP as required by section 805 of the FD&C Act and 21 CFR 1.502(a). Specifically, you did not develop an FSVP for the following food products you import:

  • Limes imported from (b)(4)
  • Limes imported from (b)(4)

2. You must conduct a hazard analysis for each type of food you import to determine whether there are any hazards requiring a control, as required by CFR 1.504(a). Although you may meet this requirement by reviewing and assessing the hazard analysis conducted by another entity using a qualified individual, you must document your review and assessment of the hazard analysis, including documenting that the hazard analysis was conducted by a qualified individual (21 CFR 1.504(d)). During our inspection you provided a hazard analysis for papaya which you obtained from (b)(4) and a document that you identified to be the hazard analysis for papaya that you obtained from (b)(4). However, you did not provide documentation that you have reviewed and assessed your foreign supplier’s hazard analysis as required by 21 CFR 1.504(d).

3. You must approve your foreign suppliers on the basis of an evaluation of your foreign supplier’s performance and the risk posed by the food, in accordance with 21 CFR 1.505(a), for the foods you import. You must consider the hazard analysis of the food, the entity or entities that would be significantly minimizing or preventing the hazards requiring a control or verifying that such hazards have been significantly minimized or prevented, the foreign supplier performance, and any other factors as appropriate and necessary. However,

  • In your Foreign Supplier Verification Form for your foreign supplier (b)(4):

   You stated you reviewed the supplier’s relevant food safety records. However, you did not document your review in accordance with 21 CFR 1.505(a)(2). Such documentation may include identifying what specific relevant food safety records were reviewed, who reviewed the records, and the date the records were reviewed.

   You identified the applicable food safety regulation in your second Question 10 of your FSV Form, which states, “List FDA regulation that the Foreign Supplier is subject to in relation to food safety.” However, you have not identified what steps you took to verify that the foreign suppliers are complying with that regulation. Question 12 on the same form states, “List the applicable Foreign Supplier Evaluation Procedure.” You state that you review food safety manuals and sample analysis reports and verify both past food safety violations and (b)(4). However, you have not identified how you verify past food safety violations.

  • You provided a document in a foreign language that you identified to be the foreign supplier evaluation for your foreign supplier of papaya, (b)(4). You may meet the requirements of 21 CFR 1.505 by complying with section 1.505(d) and reviewing and assessing another entity’s evaluation of your foreign supplier’s performance and risk posed by the food. However, we are unable to determine whether you reviewed and assessed this document, in part because you did not provide an English translation of the foreign supplier evaluation.

4. You did not meet the requirement to perform foreign supplier verification activities as required by 21 CFR 1.506. Specifically, you did not establish written procedures for ensuring that appropriate supplier verification activities are conducted in accordance with 21 CFR 1.506(b), and you did not document your determination of the appropriate supplier verification activity or activities, or the frequency with which the activity or activities must be conducted, as required by 21 CFR 1.506(d).

With respect to the requirements of 21 CFR 1.506(e), regarding the performance of foreign supplier verification activities, while you may rely on third-party food safety audits as part of your foreign supplier verification activities, you must ensure the audit is performed by a qualified auditor and considers applicable FDA food safety regulations (or, when applicable, an onsite audit may consider relevant laws and regulations of a country whose food safety system FDA has officially recognized as comparable or determined to be equivalent to that of the United States). You must also promptly review and assess any third-party audit that constitutes a verification activity, as well as document your review and assessment, among other requirements (21 CFR 1.506(e)).

For your foreign supplier (b)(4), you have identified that (b)(4) and (b)(4) are the entities that perform an onsite audit of the supplier (Question 7, FSV Form); however, you have also stated that the date of the onsite audit is “N/A” (Questions 8, FSV Form) and we are unable to evaluate the (b)(4) documents you provided during the inspection because you have not provided an English translation. Additionally, you provided a document from the entity (b)(4) that you identified as an onsite audit of your foreign supplier (b)(4), which included a link to an English translation. You did not document your review of the results of this audit, using a qualified individual.

For your foreign supplier (b)(4), you provided a document entitled “(b)(4)” that you identified as an onsite audit. This document does not list your foreign supplier’s name, and instead lists the name, “(b)(4).” You did not document your review of the results of this audit, using a qualified individual, or provide an English translation.

5. You must make all records required under this subpart available promptly to an authorized FDA representative, upon request, for inspection and copying. Upon FDA request, you must provide within a reasonable time an English translation of records maintained in a language other than English, as required by 21 CFR 1.510(b)(1). However, you did not provide an English translation of the following FSVP documents after the investigator’s request of the referenced documents in English: hazard analysis, foreign supplier evaluation documentation, and verification documentation for (b)(4); and the hazard analysis, a portion of the foreign supplier evaluation documentation (pages 1-3, 7-9, & 12-19 of the document “(b)(4) FSVP” that you provided our investigator), and a portion of the verification documentation for (b)(4). To date you have still not provided the requested translation of these documents.

The above violations are not intended to be an all-inclusive list of violations of the FSVP requirements. It is your responsibility to ensure that you are in compliance with section 805 of the FD&C Act and the implementing regulation in 21 CFR part 1, subpart L.

This letter notifies you of our concerns and provides you an opportunity to address them. If you do not adequately address this matter, we may take further action. For instance, we may take action under section 801(a)(3) of the FD&C Act (21 U.S.C. 381(a)(3)) to refuse admission of the food you import for which you appear to be in violation of section 805. We may place the foods you import into the United States from the identified foreign suppliers on detention without physical examination (DWPE) when you import the foods. You can find DWPE information relating to FSVP in Import Alert # 99-41 at http://www.accessdata.fda.gov/cms_ia/ialist.html. In addition, the importation or offering for importation into the United States of an article of food without the importer having an FSVP that meets the requirements of section 805 of the FD&C Act or the FSVP regulation is prohibited under section 301(zz) of the FD&C Act (21 U.S.C. 331(zz)).

Additionally, we offer the following comment:

The papayas you are importing are "covered produce" as defined in 21 CFR 112.3. As such, you are not required to determine whether there are any biological hazards requiring a control in such food because FDA has determined that the biological hazards in covered produce require a control and compliance with the requirements in part 112 to significantly minimize or prevent the biological hazards. Your “Foreign Supplier Verification Form” for papayas from (b)(4) contains a section that states, “Hazard(s) associated with the ingredient or product: Salmonella, E. Coli, & fecal coliforms,” which is not a requirement. However, the correct biological hazards associated with papayas are Salmonella, E. coli, and Listeria.

You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should address the specific things you are doing to correct any violations. You should include in your response documentation and information that would assist us in evaluating your response (e.g., documentation of changes you made, such as a copy of your revised FSVP, records to demonstrate implementation of your FSVP), and any additional information that you wish to supply relevant to your compliance with the FSVP regulation. If you believe that you are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration. If you cannot complete all corrections within 15 working days, you should explain the reason for your delay and state when you will correct any remaining violations.

Please send your reply to Food and Drug Administration, Attention: Feryal Ahmad, Compliance Officer, Division of Northeast Imports, ORAOEIONEIMPORTSWLResponses@fda.hhs.gov. Please also cc (carbon copy) Feryal.Ahmad@fda.hhs.gov. If you have any questions regarding this letter, you may contact Compliance Officer Ahmad via email at Feryal.Ahmad@fda.hhs.gov. Please reference CMS# 620490 on any documents or records you provide to us and/ or within the subject line of any email correspondence you send to us.

Sincerely,
/S/

CAPT Nazmul Hassan
Program Division Director
Division of Northeast Imports

 
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