FDA 483 - MSN Life Sciences Private Limited - June 03, 2022

MSN Life Sciences Private Limited, an Active Pharmaceutical Ingredient Manufacturer in Kamareddy, India, was cited with three observations during an FDA inspection. The inspection revealed significant deficiencies in data integrity, including inadequate audit trail review for analytical data, and issues with quality control, such as unscientific water sampling plans for microbial analysis and unvalidated analytical and cleaning methods. These findings indicate a lack of robust quality systems for ensuring product quality and data reliability.