FDA WARNING_LETTER - Copoliva Inc. - March 18, 2020

On June 16, 2020, the FDA issued a Warning Letter to Copoliva, Inc. following a Foreign Supplier Verification Program (FSVP) inspection on March 18, 2020, and a prior inspection on September 13, 2018. The inspections aimed to assess compliance with Section 805 of the FD&C Act and 21 CFR Part 1 Subpart L, which mandates importers to conduct risk-based activities to ensure imported food meets U.S. food safety standards.

The FDA found Copoliva, Inc. was not in compliance, specifically lacking FSVPs for Refined Rice Bran Oil, Grape Seed Oil, and Organic High Oleic Sunflower Oil, and for any other imported food products. This violates 21 CFR 1.502(a), which requires developing, maintaining, and following an FSVP. Form FDA 483a, FSVP Observations, was issued after both inspections, but no response was received.

Failure to correct these violations may lead to further action, including refusal of admission for the mentioned products under Section 801(a)(3) of the FD&C Act, and potential detention without physical examination (DWPE) under Import Alert #99-41. Importing food without a compliant FSVP is also prohibited under Section 301(zz) of the FD&C Act. Copol