FDA WARNING_LETTER - Jap Inc. dba Intercontinental Foods - March 09, 2022

On March 8-9, 2022, the FDA conducted an FSVP inspection of Jap Inc. dba Intercontinental Foods, following previous inspections in November 2018 and March 2021. The inspection revealed significant violations of the FSVP regulation (21 CFR part 1, subpart L) and section 805 of the FD&C Act, as the company failed to develop, maintain, and follow an FSVP for any imported foods. A Form FDA 483a was issued on March 9, 2022, to which no response has been received.

The FDA warns that failure to adequately address these violations may result in 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). The letter notes the company may qualify as a "very small importer" (21 CFR 1.500), which would require compliance with modified requirements, including documenting this status and obtaining written assurances from foreign suppliers every two years regarding compliance with U.S. food safety standards.

Jap Inc. must respond in writing within fifteen working days, detailing corrective actions, providing supporting documentation (e.g., a copy of their FSVP and implementation records), and explaining any delays.