FDA 483 - Micro Measurement Laboratories, Inc. - January 24, 2019

An FDA inspection of Micro Measurement Laboratories, Inc. in Wheeling, IL, a control testing laboratory, revealed significant deficiencies in quality control unit procedures, method validation, and adherence to drug product specifications. The firm failed to adequately evaluate drug product samples, validate testing methods, and ensure Certificates of Analysis met compendial requirements. This included a repeat observation regarding the suitability of testing methods.