FDA 483 - Charles River Laboratories Inc - August 25, 2023

An FDA inspection of Charles River Laboratories Inc in Memphis, TN, revealed seven observations related to significant deficiencies in their manufacturing and quality control processes. Issues included failures to follow standard operating procedures, inadequate aseptic controls, deficient containment of contaminants, and poor facility maintenance leading to pest control problems. These findings indicate a lack of robust controls over critical operations, potentially impacting product quality and safety.