FDA WARNING_LETTER - Euphoria Fancy Food Inc. - August 04, 2022

On July 19 through August 4, 2022, the FDA conducted a Foreign Supplier Verification Program (FSVP) inspection of Euphoria Fancy Food Inc. at 149 2nd Avenue, Brooklyn, NY. A previous inspection occurred on August 13, 2019. The inspections aimed to determine compliance with section 805 of the FD&C Act and 21 CFR part 1, subpart L, which requires importers to perform risk-based activities to verify imported food meets U.S. food safety standards.

During the recent inspection, Euphoria Fancy Food Inc. was found not in compliance with 21 CFR part 1, subpart L, stating they had no FSVP records for any imported foods. This constitutes a significant violation of section 805 of the FD&C Act. An FDA Form 483a FSVP Observations was issued.

The firm's August 5, 2022, email response stated they hired a consultant and received paperwork from factories but needed time for translation. The response lacked specific steps or documentation of corrective actions. The FDA found the response did not address the violations or demonstrate the development of FSVPs. Subsequent FDA emails on August 17 and August 24, 2022, requesting consultant contact information and a compliance timeline, received no response.

The primary violation is the failure to develop, maintain