FDA 483 - Quincy Bioscience Holding Company Inc. - March 09, 2015

An FDA inspection of Quincy Bioscience Manufacturing Inc. in Madison, WI, revealed severe deficiencies across multiple areas of their drug manufacturing operations. The firm failed to report numerous serious adverse events for its non-prescription drug products, including Prevagen, and conducted inadequate investigations into customer complaints and product returns. Significant issues were also identified in master production records, process validation, stability testing, and quality control procedures, indicating a broad lack of adherence to Good Manufacturing Practices.