FDA 483 - COCO LOPEZ, INC. - July 31, 2025

During an inspection conducted from July 29 to July 31, 2025, the U.S. Food and Drug Administration (FDA) issued a Form 483 to COCO LOPEZ, identifying significant deficiencies in their Foreign Supplier Verification Program (FSVP). The inspection, focusing on compliance under the Federal Food, Drug and Cosmetic Act, revealed three primary observations.

Firstly, COCO LOPEZ failed to develop an FSVP entirely, as required for imported food products, specifically noting an absence for Pink Beans. Secondly, the company did not adhere to its own established written procedures for verifying foreign suppliers. This included a failure to conduct and document product testing for imported Coconut Cream and to review food safety records for Canned Coconut Cream. Lastly, COCO LOPEZ lacked essential written procedures to ensure that all imported food products, including Coconut Cream and Canned Coconut Cream, were sourced solely from approved foreign suppliers.

These observations indicate a systemic lack of controls necessary to ensure the safety of imported foods. To address these findings, COCO LOPEZ must develop a comprehensive FSVP, establish and rigorously follow written procedures for foreign supplier approval and verification, and diligently conduct and document all required verification activities. Corrective actions are necessary to bring the company into compliance with federal regulations concerning imported food safety.