FDA 483 - Biocon Generics Inc. - September 08, 2020

EYWA PHARMA INC, a drug manufacturer in Cranbury, NJ, received a Form 483 with three observations. The inspection revealed significant deficiencies in the firm's quality control unit, including a lack of investigations into invalid test results, inadequate audit trail reviews for data acquisition systems, and poor sample labeling practices. Additionally, the firm failed to retain complete electronic raw data for laboratory testing and lacked appropriate controls over computer systems, with critical audit trail access limited to a single remote IT administrator who does not perform reviews.