FDA 483 - McGuff Pharmaceuticals, Inc. - March 26, 2019

McGuff Pharmaceuticals, Inc. in Santa Ana, CA, a sterile drug manufacturer, was cited with seven observations during an FDA inspection from March 18-26, 2019. The inspection revealed significant deficiencies in quality control, including inadequate investigations, untimely implementation of CAPAs, insufficient laboratory controls, incomplete employee training, and failures in environmental monitoring and equipment maintenance. Repeat observations from a previous inspection indicate persistent issues with training and microbiological contamination prevention.