FDA 483 - Quality CDMO - June 16, 2023

An FDA inspection of QUALITY CDMO, Inc. in Fort Worth, TX, a drug manufacturer, revealed significant deficiencies in their manufacturing processes. The firm failed to validate drug manufacturing equipment, equipment qualifications, and cleaning procedures for OTC and Rx drug products. Additionally, the quality control unit lacked proper authority for change control, and the firm had not established hold time studies for bulk drug products.