KUIYI INTERNATIONAL INC. – FDA Warning Letter, Mar 5, 2021

The FDA issued a Warning Letter to Kuiyi International Inc. following inspections conducted from February 11 to March 5, 2021, and previously on April 24, 2019. The inspections assessed compliance with the Foreign Supplier Verification Program (FSVP) regulation (21 CFR part 1 subpart L) under section 805 of the FD&C Act.

The primary violation identified was the firm's failure to develop, maintain, and follow an FSVP for any imported food products, including Baked Rice Chips, Unif Kumquat Green Tea, Unif Sneaking Around Tea, and (b)(4) Potato Chips. This non-compliance was particularly significant as the recent inspection was a follow-up to a consumer complaint involving an anaphylactic reaction due to undeclared milk allergens in (b)(4) Potato Chips, which constitutes a serious adverse health consequence (SAHCODHA) hazard.

The firm received Form FDA 483a, FSVP Observations, after both the 2019 and 2021 inspections but failed to provide a response to either. The FDA cited 21 CFR 1.502(a)1 for the lack of an FSVP.

Failure to adequately address these violations may result in refusal of admission for imported food products under section 801(a)(3) of the FD&C Act, potential detention without physical examination