Charles River Laboratories Inc – FDA 483

An FDA inspection of Charles River Laboratories, Inc. in Memphis, TN, revealed significant deficiencies in their operations. The firm's Quality Assurance oversight was found to be inadequate in managing deviations, investigations, and corrective actions in a timely manner. Additionally, environmental controls and manufacturing processes were insufficient to ensure product sterility, leading to microbial contamination, and raw material testing procedures were deficient.