FDA 483 - BioZone Laboratories Inc. - January 26, 2016

BioZone Laboratories Inc. in Pittsburg, CA, a drug contract manufacturer, was inspected from January 13-26, 2016. The inspection revealed significant deficiencies in laboratory controls, including lack of electronic record validation and audit trails, inadequate storage conditions for raw materials and drug products, and uncalibrated analytical equipment. Additionally, the firm failed to perform annual drug product reviews as per their own procedures.