FDA 483 - Pacira Pharmaceuticals, Inc. - July 22, 2015

An FDA inspection of Pacira Pharmaceuticals, Inc. in San Diego, CA, a drug manufacturer, revealed significant deficiencies across its facilities, equipment, production, and laboratory control systems. The firm failed to adequately maintain and qualify equipment, lacked proper cleaning procedures for stability chambers, and exhibited shortcomings in its investigation of discrepancies and documentation practices. These issues indicate a lack of adherence to current Good Manufacturing Practices, potentially impacting drug product quality and safety.