FDA WARNING_LETTER - TL State Management, Inc. - April 18, 2022

On March 21-April 18, 2022, the FDA inspected TL State Management, Inc. in Brooklyn, NY, following a previous inspection from June 2-19, 2020. The inspections assessed compliance with the Foreign Supplier Verification Program (FSVP) regulation (21 CFR part 1, subpart L) under section 805 of the FD&C Act.

The FDA found the company not in compliance with FSVP requirements for imported foods. A significant violation identified was the failure to develop, maintain, and follow an FSVP as required by 21 CFR 1.502(a) for any imported food products. The company did not respond to the Form FDA 483a FSVP Observations issued on April 18, 2022.

Failure to address these violations may result in 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.

TL State Management, Inc. must respond in writing within fifteen working days, detailing corrective actions, providing supporting documentation (e.g., a copy of their FSVP and implementation records), or explaining any delays