FDA 483 - Pharmaceutics International Inc - November 16, 2017

Pharmaceutics International Inc in Hunt Valley, MD, received a Form 483 citing significant deficiencies in laboratory controls, record-keeping, and equipment management. Issues included inadequate assay testing procedures, improper handling of out-of-specification results, deficient calibration procedures, and failures in OOS and CAPA investigations. Additionally, problems with sample handling, equipment qualification, and environmental controls were noted, indicating a broad lack of adherence to cGMP.