FDA 483 - Yusef Manufacturing Laboratories, LLC - May 26, 2016

An FDA inspection of Yusef Manufacturing Laboratories, LLC in Clearfield, UT, revealed numerous significant and repeat violations of current Good Manufacturing Practices for OTC drug products. The firm failed to maintain adequate quality control, conduct proper product and component testing, ensure microbial control, manage production records, calibrate equipment, provide sufficient employee training, and address customer complaints, indicating systemic deficiencies in their manufacturing operations.