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

Quincy Bioscience Manufacturing Inc. in Madison, WI, a dietary supplement manufacturer and distributor, was cited for failing to report serious adverse events associated with its product, Prevagen. The inspection revealed numerous instances of unreported serious adverse events, including seizures, strokes, and worsening chronic conditions, many requiring medical attention or hospitalization. The firm also failed to follow its internal procedures for investigating and documenting these adverse events.