FDA WARNING_LETTER - J & H Imports Services Corp. - November 28, 2022

On March 13, 2023, the FDA issued a Warning Letter to J&H Imports Services Corp. following a Foreign Supplier Verification Program (FSVP) inspection conducted from November 7 to November 28, 2022. Previous inspections occurred on October 28, 2019, and November 16-23, 2021. The inspection determined the firm was not in 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.

The significant violation identified was the firm's failure to develop, maintain, and follow an FSVP for any imported foods, as required by 21 CFR part 1.502(a). The FDA investigator issued a Form FDA 483a, FSVP Observations, on November 28, 2022, to which no response was received.

Failure to adequately address this violation may result in further FDA action, including refusal of admission for imported food products under Section 801(a)(3) of the FD&C Act, and placement on detention without physical examination (DWPE) under Import Alert #99-41. The importation of food without a compliant FSVP is prohibited under Section 301(zz) of