FDA WARNING_LETTER - Talla Imports LLC - December 16, 2024

On January 13, 2025, the FDA issued a Warning Letter to Talla Imports Inc. following a Foreign Supplier Verification Program (FSVP) inspection conducted from November 20 to December 16, 2024. The inspection found the company non-compliant with section 805 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and 21 CFR part 1, subpart L, which mandates risk-based activities to verify imported food meets U.S. safety standards.

The primary violation identified was the failure to develop, maintain, and follow an FSVP for any imported foods, as required by 21 CFR 1.502(a). A Form FDA 483a FSVP Observations was issued on December 16, 2024, to which no response had been received.

The FDA stated that failure to adequately address these violations could lead to further action, including refusal of admission for imported food under section 801(a)(3) of the FD&C Act, and placement on detention without physical examination (DWPE) via Import Alert # 99-41. Additionally, importing food without a compliant FSVP is prohibited under section 301(zz) of the FD&C Act.

Talla Imports Inc. is required to respond in writing within fifteen working days, detailing corrective actions, providing supporting