Coastal Meds, LLC – FDA 483, Nov 10, 2014

During an FDA inspection conducted from October 20 to November 10, 2014, Coastal Meds, LLC, a producer of sterile drug products in Biloxi, MS, received a Form FDA 483 detailing significant deviations from manufacturing standards. The observations highlighted critical issues in the production of sterile injectable drug products. Key violations included deficiencies in aseptic processing areas, specifically the absence of smoke studies to determine airflow patterns and the lack of a Laminar Air Flow Hood (LAFH). The firm also failed to validate its sterilization processes for products and closures, even filling/sealing sterile products in an unclassified room. Furthermore, Coastal Meds did not thoroughly investigate batch failures, including numerous lots that failed potency specifications, and failed to investigate complaints regarding product discoloration and an adverse drug event. The company lacked essential quality control testing, specifically sterility and endotoxin testing according to USP standards. Product expiration dates were not supported by appropriate stability data, as no stability testing program or protocols were in place. Additional concerns included inadequate control over unlabeled vials, unestablished time limits for production phases, and unsuitable facility construction, such as a sink used for trash storage. These observations indicate a failure to adhere to Current Good Manufacturing Practices (CGMP) for sterile drug production. Coastal Meds, LLC, is required to promptly address these findings by developing and implementing comprehensive corrective actions to ensure product quality and patient safety.