FDA 483 - MSN PHARMACEUTICALS INC. - June 16, 2021

MSN Pharmaceuticals Inc. in Piscataway, NJ, was inspected and received 11 observations primarily related to significant data integrity issues, inadequate quality control, and insufficient documentation for manufacturing processes and product testing. The inspection revealed deficiencies in batch record accuracy, sampling plans, stability studies, water quality, equipment cleaning, personnel training, laboratory controls, and master production records, indicating a broad lack of adherence to GMP standards.