FDA 483 - Good Health Manufacturing - August 20, 2021

Good Health Manufacturing received a Form 483 detailing multiple significant violations related to the manufacturing and control of dietary supplements. Observations included inadequate cleaning and sanitization, poor contamination control during manufacturing, and a lack of established product and component specifications. The firm also failed to maintain proper documentation for supplier qualification, batch production records, and master manufacturing records, alongside issues with environmental controls, personnel gowning, and equipment suitability and calibration.