FDA 483 - Charles River Laboratories, Inc. - January 04, 2024

An FDA inspection of Charles River Laboratories, Inc. in Malvern, PA, a control testing laboratory, revealed significant deficiencies in their quality control systems. The firm failed to establish adequate written procedures for production and process controls, as their environmental monitoring system repeatedly missed critical deviations in cleanrooms and biological safety cabinets. Furthermore, investigations into these discrepancies were found to be inadequate, lacking thoroughness in addressing system failures and assessing product impact.