FDA 483 - Stratus Pharmaceuticals Inc - December 08, 2014

Stratus Pharmaceuticals Inc. in Miami, FL, was cited for significant deficiencies in its quality control unit, complaint handling procedures, and employee training during an FDA inspection. The firm failed to adequately investigate and report over a thousand product complaints, including those related to product quality and potential adverse events. These issues indicate a systemic breakdown in critical quality assurance processes and compliance with cGMP regulations.