FDA 483 - Pharmaceutical Manufacturing Research Services, Inc (PMRS) - May 25, 2017

An FDA inspection of Pharmaceutical Manufacturing Research Services, Inc. (PMRS) in Horsham, PA, from May 22-25, 2017, identified significant deficiencies in the firm's instrument calibration procedures. Specifically, issues were noted with the calibration of dissolution apparatus and pH meters, which are critical for testing stability samples and releasing finished drug products. These findings indicate a lack of adequate control over analytical equipment and testing processes.