USA – Agroson’s LLC – FDA Warning Letter – Salmonella

FDA

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.

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: SalmonellaE. Coli, & fecal coliforms,” which is not a requirement. However, the correct biological hazards associated with papayas are SalmonellaE. coli, and Listeria.

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