FDA WARNING_LETTER - FMT Services, LLC - March 22, 2021

On March 22, 2021, the FDA conducted a Foreign Supplier Verification Program (FSVP) inspection of FMT Services LLC, following a previous inspection on September 11, 2018. The inspections aimed to assess compliance with section 805 of the FD&C Act and 21 CFR part 1 subpart L, which mandate risk-based activities for importers to verify food safety standards.

The FDA found that FMT Services LLC is not in compliance with FSVP requirements for corn flour and quicklime imported from foreign supplier (b)(4), and quicklime imported from foreign supplier (b)(4). Specifically, the company failed to develop, maintain, and follow an FSVP for these products, violating 21 CFR 1.502(a). Form FDA 483a, FSVP Observations, was issued after both inspections, but no response has been received.

Failure to address these significant violations may lead to further action, including refusal of admission for the imported products 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 also prohibited under section 301(zz) of the FD&C Act.

FMT Services LLC must respond in writing within fifteen working days, detailing corrective actions, providing supporting documentation (e