FDA 483 - Protein Sciences Corporation - May 02, 2024

During an inspection conducted from April 23 to May 2, 2024, the U.S. Food and Drug Administration (FDA) issued a Form 483 to Protein Sciences Corporation, a licensed biological drug substance manufacturer in Pearl River, NY. The observations highlight significant deficiencies in the company's manufacturing and quality control systems, indicating potential non-compliance with Good Manufacturing Practices.

Key issues included inadequate laboratory controls, specifically the use of an insufficient testing procedure for releasing Flublok drug products to the U.S. market, and the unjustified invalidation of Out-of-Specification results without proper manufacturing investigations or effectiveness reviews of corrective actions. Furthermore, the FDA noted a failure to conduct thorough investigations into discrepancies and deviations, such as material handling issues and high rates of invalidated test results for a drug substance method.

The inspection also revealed a lack of proper documentation for manufacturing deviations, with operators not always recording critical events, and the absence of an inventory system for tracking manufacturing materials. Environmental monitoring was found to be deficient, lacking clear alarm response procedures and monitoring in certain critical areas. Finally, facility design and maintenance were cited, with observations of a raw material sampling booth that could lead to contamination and poor cleanliness within a Grade C cleanroom. Protein Sciences Corporation is required to promptly address these observations with comprehensive corrective and preventive actions.