FDA 483 - COCACOLA SOUTHWEST BEVERAGES LLC - September 17, 2025

An FDA inspection conducted from September 15-17, 2025, identified significant deficiencies in the Foreign Supplier Verification Program (FSVP) of an importing firm. The primary violation observed was the complete absence of an FSVP, a mandatory requirement under Section 805 of the Federal Food, Drug and Cosmetic Act. Specifically, the firm failed to develop any FSVP, and consequently, no records were available for review by the FDA investigators. This issue was noted concerning imported Coca Cola from a foreign supplier. The regulatory framework governing this observation is the Foreign Supplier Verification Program for Importers of Food for Humans and Animals. The lack of an established FSVP is a critical non-compliance, as it directly impacts the firm's ability to ensure that imported food meets U.S. safety standards. To address these findings, the firm is required to promptly develop and implement a comprehensive FSVP for all applicable imported food products, including Coca Cola. This program must include documented procedures for hazard analysis, supplier verification, and corrective actions, as well as maintaining thorough records to demonstrate compliance with FDA regulations. Failure to establish and maintain an FSVP could lead to further regulatory action.