FDA 483 - QOL Medical LLC - August 27, 2019

An FDA inspection of QOL Medical, LLC in Clearwater, FL, a drug substance manufacturer, revealed a significant issue concerning the firm's equipment management. The company failed to properly execute and document its preventive maintenance program, specifically regarding the calibration of critical equipment used in the manufacturing of Sacrosidase Drug Substance. This indicates a deficiency in maintaining equipment in a state of control.