FDA 483 - Coca-Cola North America - Atlanta Syrup Branch - December 19, 2024

During an inspection conducted from December 16-19, 2024, the FDA issued a Form 483 to Coca-Cola North America - Atlanta Syrup Branch, a manufacturer of various concentrates and syrups. The primary observation noted that the company's hazard analysis failed to identify the significant risk of pathogen growth and toxin formation stemming from poor formulation control for ambient-stored products. An example from June 2022 highlighted this, where a batch of Gold Peak Southern Style Tea was released with an out-of-specification pH, leading to its withdrawal due to a food safety risk. The inspection further revealed inadequate written procedures for controlling this hazard, specifically concerning monitoring, corrective actions, and verification. There was also a lack of consistent and timely supervisory review of laboratory data, with significant gaps in documentation. This intermittent oversight raised concerns that products failing specification could potentially reach the market. Under the Federal Food, Drug, and Cosmetic Act, firms must maintain robust food safety plans. Coca-Cola North America is required to address these observations by implementing comprehensive corrective actions, including revising its hazard analysis and establishing clear, documented procedures for monitoring and verifying product specifications to ensure consumer safety.