FDA 483 - MSN LIFE SCIENCES PRIVATE LIMITED - September 13, 2024

An FDA inspection of MSN Life Sciences Private Limited, Unit II, an API manufacturer in Chandampet, Telangana, India, revealed significant deficiencies in quality control and facility maintenance. The firm failed to thoroughly investigate out-of-specification (OOS) and out-of-trend (OOT) results, and its quality unit did not adequately review critical deviations or ensure proper investigation and resolution. Additionally, the production areas lacked adequate washing facilities with hot water for personnel.