FDA WARNING_LETTER - Five Star Trading IL, Inc. - December 12, 2022

On November 21, 2022, to December 12, 2022, the FDA conducted an FSVP inspection of Five Star Trading IL, Inc. and found significant violations of the FSVP regulation (21 CFR part 1, subpart L) and section 805 of the FD&C Act.

The company failed to develop, maintain, and follow an FSVP for imported foods, as required by 21 CFR §1.502(a). They also did not conduct and document required supplier verification activities for foreign suppliers of dried black peppercorn and dried black fungus, as per 21 CFR 1.506(e). Specifically, while an FSVP for dried black peppercorn listed several verification activities, only finished product testing was documented. For dried black fungus, only the foreign supplier’s HACCP plan and SSOPs were provided, despite other listed activities.

Furthermore, the company did not promptly document their review and assessment of verification activity results, as required by 21 CFR 1.506(e)(3), for dried black peppercorn and dried black fungus. They also failed to provide an English translation of a finished product laboratory report for dried black peppercorn upon FDA request, violating 21 CFR 1.510(b)(1).

Failure to adequately address these violations may result in refusal of admission for imported food