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

During an inspection conducted from August 21 to August 25, 2023, the U.S. Food and Drug Administration (FDA) issued a Form 483 to Charles River Laboratories Inc. in Memphis, TN. The inspection identified several concerning conditions and practices at the manufacturing facility. Key observations included a pervasive failure to adhere to established standard operating procedures across various operations. Specifically, inspectors noted issues such as improper labeling of rejected raw materials, multiple deviations from aseptic techniques during drug product manufacturing, and incorrect biological safety cabinet usage. There were also concerns regarding inadequate containment measures for potential contaminants and deficient aseptic controls within critical manufacturing environments, including the lack of validation for cleaning and sanitization processes for tools used in sterile areas. Furthermore, the facility was cited for not sterilizing Batch Production Records and labels before transferring them into cleanrooms. A significant issue involved the physical state of the warehouse, which exhibited neglected repairs, leading to increased pest and insect infestations. The firm's standard operating procedure for cold storage alarm response was found to be insufficient, lacking critical details for handling material during freezer failures. Finally, the visual inspection process qualification for drug products was deemed deficient, as the training and qualification sets did not accurately represent final product vials. Charles River Laboratories is expected to address these observations by implementing appropriate corrective actions to ensure compliance with regulatory standards.