FDA 483 - Azurity Pharmaceuticals, Inc. - January 15, 2020

CutisPharma, Inc. in Wilmington, MA, was inspected as a testing laboratory and received a Form 483 with two observations. The inspection revealed significant issues with the establishment of test method accuracy and equipment qualification, as well as a failure to thoroughly investigate customer complaints and unexplained discrepancies. These findings indicate deficiencies in quality control and complaint handling processes.