FDA 483 - Quincy Bioscience Holding Company Inc. - November 04, 2016

Quincy Bioscience Holding Company Inc. received a Form 483 citing significant deficiencies in its quality control and manufacturing processes for dietary supplements. Key issues include repeated failures to report serious adverse events and adequately investigate product complaints, along with a lack of scientifically valid methods, proper process controls, and validated equipment. The firm also failed to maintain adequate documentation, including master manufacturing records and product specifications, indicating systemic quality management failures.