Willis Ocean Inc. – FDA Warning Letter, Mar 5, 2020

The FDA conducted Foreign Supplier Verification Program (FSVP) inspections at Willis Ocean Inc. on December 13 and 21, 2017, and a follow-up on March 5, 2020, to assess compliance with section 805 of the FD&C Act and 21 CFR part 1 subpart L. The inspections revealed significant violations, primarily that the firm failed to develop, maintain, and follow an FSVP as required by 21 CFR 1.502(a). Specifically, Willis Ocean Inc. did not have FSVPs for imported Frozen Vegetarian Food and Chinese Noodle. While a previous issue regarding Spicy Beef Flavor Paste was noted in 2017, the firm stated they terminated its import. This failure indicates the firm did not perform required risk-based activities to verify imported food meets U.S. safety standards. The FDA requires prompt corrective action and a written response within fifteen working days, including documentation such as a copy of the FSVP and implementation records. Failure to comply may result in refusal of admission for affected products, placement on Detention Without Physical Examination (DWPE) under Import Alert # 99-41, and prohibition of importation under section 301(zz) of the FD&C Act.