FDA WARNING_LETTER - Fides Ny Inc - May 28, 2020

On May 26 and 28, 2020, the FDA conducted a remote Foreign Supplier Verification Program (FSVP) inspection of Fides New York Inc., following an initial on-site inspection on June 6, 2018. The inspections aimed to assess compliance with section 805 of the Federal Food, Drug and Cosmetic Act (FD&C Act) and 21 CFR part 1 subpart L, which mandate risk-based activities for importers to ensure imported food meets U.S. safety standards.

The FDA found Fides New York Inc. was not in compliance with FSVP requirements for imported food products, including Namja Ramen, Aloe Drink, and Frozen Yogurt Drink Green Apple Flavor. The firm lacked FSVPs for these and all other imported products, constituting significant violations of section 805 of the FD&C Act.

Following both the 2018 and 2020 inspections, the investigator issued Form FDA 483a, FSVP Observations, but the FDA has not received a response to either.

The FDA requires prompt corrective action. Failure to comply may lead to refusal of admission for imported food 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 prohibited under section 301