FDA 483 - Charles River Laboratories, Inc. - February 11, 2020

An FDA inspection of Charles River Laboratories, Inc. in Wilmington, MA, a contract testing laboratory, revealed significant deficiencies. Observations included inadequate environmental controls for temperature and humidity monitoring, a failure to thoroughly investigate unexplained discrepancies, and insufficient cleaning of equipment and utensils. These issues indicate a lack of proper controls over drug product manufacturing and quality processes.