FDA 483 - Cosco International, Inc. - October 25, 2024

The FDA conducted an inspection of Cosco International, Inc., an over-the-counter (OTC) drug manufacturer in Marietta, GA, from October 15 to October 25, 2024. The inspection revealed multiple significant deviations from Current Good Manufacturing Practices (cGMP). Primary violations included a widespread lack of validation for critical manufacturing processes, such as the water purification system, drug product manufacturing, and equipment cleaning, with some issues being repeat observations from prior inspections. The company also failed to perform adequate microbiological testing for water and components, and did not properly identify objectionable microorganisms. Numerous drug products were distributed without sufficient stability data to establish reliable expiration dates, another recurring concern. Further issues involved deficient procedures for investigating out-of-specification results and customer complaints. Critical data integrity weaknesses were observed, including inappropriate user access and data manipulation in analytical systems like HPLC, alongside a lack of comprehensive data integrity policies. Additionally, the firm was found to have used expired or inadequately tested raw materials in drug production and maintained incomplete distribution records. Cosco International is required to implement comprehensive corrective actions to address these systemic deficiencies and ensure compliance with federal regulations governing drug product quality and safety.