FDA 483 - Quincy Bioscience Holding Company, Inc. - December 22, 2011

An FDA inspection of Quincy Bioscience Manufacturing Inc. in Middleton, WI, revealed significant deficiencies in their dietary supplement manufacturing processes. The firm failed to verify finished product identity, adhere to master production records, follow laboratory procedures, establish adequate in-process specifications, and maintain complete master manufacturing records. These issues indicate a lack of robust quality control and documentation for their products, including Prevagen.