FDA 483 - MSN Laboratories Private Limited (Formulations Division, Unit-II) - November 15, 2019

An FDA inspection of MSN Laboratories Private Limited (Formulations Division, Unit-II) in Rangareddy District, India, revealed significant deficiencies in their manufacturing of human drug products. Observations included inadequate procedures to prevent microbial contamination in sterile products, insufficient cleaning and maintenance of equipment, and inconsistent practices for visual inspection of injectable products. The firm also lacked proper statistical procedures for evaluating reserve samples, indicating a broad range of quality control issues.