FDA 483 - Park Avenue Compounding - September 11, 2025

An FDA inspection conducted at Park Avenue Compounding, an outsourcing facility located in Saint Louis, MO, from September 11 to September 23, 2025, identified significant deficiencies in its manufacturing operations. The observations highlight concerns regarding adherence to current Good Manufacturing Practices (cGMP) for sterile drug production. Key issues included inadequate validation of aseptic processes, specifically with media fills not accurately representing production batch sizes and the unexplained destruction of media fill units. Deficiencies were also noted in the cleaning and disinfection procedures for aseptic processing areas, where cleaning technicians compromised sterile environments without proper gowning changes. Furthermore, the inspection revealed compromised unidirectional airflow in ISO-5 classified areas during aseptic operations due to personnel practices, and an inadequate risk assessment for material transfer and environmental monitoring. The firm also failed to thoroughly review manufacturing discrepancies and batch failures, with examples of inconsistent deviation records, incorrect root cause analyses, and unimplemented corrective actions, such as a phenylephrine batch found to have 0% potency due to incorrect API amounts. These observations necessitate comprehensive corrective and preventive actions from Park Avenue Compounding to ensure the sterility assurance, quality, and safety of its drug products in accordance with regulatory expectations.