FDA 483 - GROCERY OUTLET INC. - June 17, 2025

During an FDA inspection conducted from June 11 to June 17, 2025, a firm located in Emeryville, CA, was cited for a significant observation regarding its Foreign Supplier Verification Program (FSVP). The inspection, which focused on the firm's compliance with foreign supplier regulations, identified that the company did not develop an FSVP for some of the foods it imports. Specifically, the firm acknowledged the absence of an FSVP for certain imported food products and their respective foreign suppliers, as documented in an attached list covering imports between June 1, 2024, and May 31, 2025. This deficiency represents a non-compliance with regulatory requirements under Section 805 of the Federal Food, Drug and Cosmetic Act, which mandates such programs to ensure the safety of imported foods. While the FDA 483 document itself lists observations and not a final determination, it highlights a critical area requiring immediate corrective action. The firm is expected to develop and implement a comprehensive FSVP for all applicable imported foods to rectify this observation and ensure compliance with federal food safety regulations.