FDA 483 - MSN Laboratories Private Limited (Formulations Division, Unit-II) - June 20, 2019

An FDA inspection of MSN Laboratories Pvt. Ltd. (Formulations Division, Unit-II) in Rangareddy District, Telangana, India, identified a significant concern regarding the manufacturing process. The firm failed to establish appropriate time limits and other critical parameters for production equipment during equipment qualification. This deficiency impacts the assurance of drug product quality.