Sun Pharmaceutical Industries, Inc. – FDA 483, Dec 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.