FDA WARNING_LETTER - OCM Group USA Inc. - May 19, 2020

On October 16, 2020, the FDA issued a Warning Letter to OCM Group USA Inc. following remote Foreign Supplier Verification Program (FSVP) inspections conducted from May 15-19, 2020, and previously on August 29, 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 perform risk-based activities to verify imported food meets U.S. safety standards.

The FDA found OCM Group USA Inc. was not in compliance, specifically for imported Crushed Chili and Sesame. The primary violation cited was the failure to develop, maintain, and follow an FSVP for any imported food products, as required by 21 CFR 1.502(a). Despite a letter from OCM Group USA Inc. outlining intentions to implement an FSVP, including obtaining Quality Management Systems Certificates, Product Specifications, Laboratory Analysis, and HACCP System Certificates from manufacturers, the FDA deemed the response inadequate due to a lack of review records, application details, and specific product information or timeframes. The company also failed to provide details on hazard analysis or supplier evaluation.

The FDA noted that relying on HACCP and QMS certificates requires compliance with 21 CFR 1.505 for foreign supplier approval and verification, and 21 CFR 1.50