FDA EIR - Charles River Laboratories, LLC - January 17, 2020

Charles River Laboratories Ashland, LLC underwent a preannounced Good Laboratory Practice (GLP) data integrity inspection by the FDA, initiated by the Center for Veterinary Medicine, from January 6 to January 17, 2020. This comprehensive inspection reviewed various aspects, including facilities, operations, personnel, equipment, quality assurance, and study performance, under the regulatory framework of Compliance Program 7348.808. During the inspection, no formal FDA Form 483 (Inspectional Observations) was issued. The inspector discussed two observations with management: certain materials were found stored directly on the floor in the formulations bulk storage room, and the Purified Water Supply Standard Operating Procedure (SOP) lacked specificity regarding certain water systems. Both issues were voluntarily and immediately corrected by the firm before the inspection concluded, with the materials placed on pallets and the SOP updated. Furthermore, the inspection verified that all corrective actions from the previous FDA inspection (conducted in July-August 2018), which included issues related to undocumented protocol deviations, SOP non-compliance, water system documentation, storage practices, and labeling, had been successfully implemented. The report concludes with no refusals encountered and no samples collected, indicating a generally compliant inspection outcome with prompt resolution of noted observations.