FDA 483 - MSN Laboratories Private Limited - December 11, 2025

MSN Laboratories Private Limited, a sterile drug manufacturer in Farooqnagar Mandal, India, was cited for significant deficiencies during an FDA inspection. Observations included failures in equipment performance qualification, inadequate raw material testing, and a quality unit that did not follow procedures for approving specifications and releasing batches. Additionally, the firm lacked scientifically sound environmental monitoring practices and laboratory controls for product quality assurance.