WINFULL CORPORATION – FDA Warning Letter, Mar 15, 2022

On June 9, 2022, the FDA issued a Warning Letter to Winfull Corporation following a Foreign Supplier Verification Program (FSVP) inspection from March 7-15, 2022, and a previous inspection concluding April 24, 2020. The inspections found the company non-compliant with section 805 of the FD&C Act and 21 CFR part 1, subpart L, which mandates risk-based activities to verify imported food meets U.S. safety standards.

Significant violations include: 1. Failure to develop, maintain, and follow an FSVP for any imported foods, as required by 21 CFR 1.502(a). 2. Failure to verify and document that imported thermally processed low-acid canned foods (e.g., AA Grade Grass Jelly Drink Beverage Base, Kidney Beans) were produced in accordance with 21 CFR part 113, as required by 21 CFR 1.502(b)(1).

The company also failed to provide a response to the Form FDA 483a issued on March 15, 2022. Additionally, the company did not provide correct importer information, specifically a valid unique facility identifier (DUNS number), for imported food entries as required by 21 CFR 1.509(a). The letter notes that if Winf