FDA 483 - Sun Pharmaceutical Industries, Inc. - December 23, 2019

PharmaLucence, Inc. in Billerica, MA, was inspected and received a Form 483 with four observations. The inspection revealed significant issues including inadequate investigations into out-of-specification results, failures in equipment qualification and requalification, lack of proper incoming raw material testing, and improper storage of reserve drug product samples. These findings indicate a moderate level of non-compliance with GMP regulations, particularly concerning quality control and equipment management.