FDA WARNING_LETTER - Anglo Freight USA Inc. - July 01, 2024

The FDA issued a Warning Letter to Anglo Freight USA Inc. following a Foreign Supplier Verification Program (FSVP) inspection from May 20, 2024, to July 1, 2024. This was the third FSVP inspection, with previous ones in 2022 and 2023. The inspection found the company non-compliant with 21 CFR part 1, subpart L, and section 805 of the FD&C Act.

The primary violation is the failure to develop, maintain, and follow an FSVP for any imported foods, as required by 21 CFR 1.502(a). Although the company indicated it operates as a "very small importer" under 21 CFR 1.500, it failed to document this status (21 CFR 1.512(b)(1)(i)) and did not obtain required written assurances from foreign suppliers every two years (21 CFR 1.512(b)(3)(i)). The company's response to the FDA 483a form was deemed inadequate due to a lack of FSVP documentation.

Additionally, Anglo Freight USA Inc. is subject to food facility registration under section 415 of the FD&C Act and 21 CFR part 1, subpart H, but has not registered its facility. Failure to register is a prohibited act under