FDA 483 - MSN Laboratories Private Limited, Unit-II - March 22, 2024

An FDA inspection of MSN Laboratories Private Limited, Unit-II in Sangareddy, India, from March 18-22, 2024, identified a significant issue with facility maintenance. The firm failed to properly maintain buildings and facilities used in API manufacturing in a clean condition. This was evidenced by observations of water staining and unknown residue on ceiling tiles and baseboards in various sample storage rooms.