FDA WARNING_LETTER - Tropic Trading Co. - August 13, 2021

On December 6, 2021, the FDA issued a Warning Letter to Tropic Trading Company following Foreign Supplier Verification Program (FSVP) inspections on August 11 and 13, 2021, and October 23, 2020. The inspections aimed to assess compliance with Section 805 of the FD&C Act and 21 CFR Part 1, Subpart L.

The FDA found Tropic Trading Company non-compliant with FSVP requirements, specifically failing to develop, maintain, and follow an FSVP for any imported foods, as required by 21 CFR Part 1.502(a). This constitutes a significant violation of Section 805 of the FD&C Act. The company had not responded to the Form FDA 483a FSVP Observations issued on August 13, 2021.

Failure to adequately 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.

Tropic Trading Company must respond in writing within fifteen working days, detailing corrective actions, providing supporting documentation (e.g., a copy of