FDA WARNING_LETTER - Alymar LLC - January 11, 2022

On January 3 and 11, 2022, the FDA conducted a Foreign Supplier Verification Program (FSVP) inspection of Alymar LLC in Houston, Texas, following a previous inspection on January 13, 2020. The inspections aimed to assess compliance with section 805 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the FSVP regulation (21 CFR part 1, subpart L).

The FDA found Alymar LLC not in compliance with FSVP requirements for imported foods. Specifically, the company failed to develop, maintain, and follow an FSVP as required by 21 CFR part 1.502(a) for any imported foods. An FDA Form 483a FSVP Observations was issued on January 11, 2022, but no response has been received.

Failure to address these violations may lead to further FDA action, including refusal of admission for imported food under section 801(a)(3) of the FD&C Act, and potential detention without physical examination (DWPE) under Import Alert # 99-41. Importing food without a compliant FSVP is prohibited under section 301(zz) of the FD&C Act.

Alymar LLC must respond in writing within fifteen working days, detailing corrective actions, providing supporting documentation, and explaining any delays. The company operates a warehouse