FDA 483 - Cosco Enterprises Inc. - March 26, 2024

During an inspection conducted from March 21-26, 2024, the FDA cited Cosco Enterprises Inc., an over-the-counter (OTC) drug manufacturer, for significant deviations from current Good Manufacturing Practice (CGMP) regulations for drug products. The observations primarily focused on the production of Tincture of Green Soap U.S.P. Key violations included a failure to adhere to the written stability testing program, incomplete testing of drug product components, and the absence of scientifically sound raw material specifications. The firm also lacked crucial control procedures such as qualification for its purified water system and manufacturing equipment, process validation, and cleaning validation. Batch production and control records were deficient, missing essential details like actual ingredient weights, equipment identification, and process parameters. Further issues involved inadequate calibration of instruments and scales, neglected annual product reviews, and a lack of proper equipment use and cleaning logs. Notably, several observations, including insufficient employee CGMP training and inadequate raw material storage conditions, were repeats from previous inspections in 2011 and 2016. Cosco Enterprises Inc. is expected to promptly address these systemic issues by developing and implementing robust corrective and preventive actions to ensure compliance with regulatory standards for drug product quality and safety.