FDA 483 - Charles River Laboratories Inc - February 07, 2025

Charles River Laboratories Inc. in Memphis, TN, a cell therapy manufacturer, received a Form 483 with five observations. The inspection revealed significant deficiencies in employee training, master production records, aseptic process validation, facility maintenance, and inventory control for raw materials and finished products. These issues indicate a lack of adequate controls to ensure the quality and sterility of drug products.