FDA WARNING_LETTER - Titans Global Inc. - August 02, 2022

On October 27, 2022, the FDA issued a Warning Letter to Titans Global Inc. following Foreign Supplier Verification Program (FSVP) inspections conducted from July 20 to August 2, 2022, and previously on May 4, 2021. The inspections aimed to assess compliance with section 805 of the FD&C Act and 21 CFR part 1, subpart L, which mandates importers perform risk-based activities to verify imported food meets U.S. food safety standards.

The FDA found Titans Global Inc. was not in compliance, specifically failing to develop, maintain, and follow an FSVP for any imported foods, a violation of 21 CFR 1.502(a). An FDA 483a, FSVP Observations, was issued on August 2, 2022, to which no response was received.

Due to these significant violations, the firm is non-compliant with section 805 of the FD&C Act. Failure to adequately address these issues may result in further FDA action, including refusal of admission for imported food under section 801(a)(3) of the FD&C Act, potential detention without physical examination (DWPE) under Import Alert # 99-41, and prohibition of importation under section 301(zz) of the FD&C Act.

Titans