FDA EIR - Charles River Laboratories, Inc. - May 14, 2010

This FDA inspection report details a surveillance inspection conducted at Charles River Laboratories, Inc. in Horsham, PA, from May 10 to May 14, 2010. The inspection was a routine Good Laboratory Practice (GLP) review for nonclinical laboratories, aligning with the PDUFA program requirements. Its scope included auditing two completed study protocols, raw data, and final reports, alongside a comprehensive facility inspection encompassing laboratories, animal study rooms, test article storage, and study archives. A review of various approved Standard Operating Procedures (SOPs) covering management responsibility, quality assurance, maintenance, sanitation, environmental controls, and training was also performed. Charles River Laboratories continues to conduct animal research studies in specialized areas such as photobiology, reproductive toxicology, and neurobehavioral toxicology. Significantly, the inspection concluded without the issuance of an FDA Form 483, indicating no official objectionable conditions were observed. However, the inspection team identified five discussion points, which were communicated verbally to the company's management at the inspection's close. In response, Charles River Laboratories committed to providing a written response addressing each of these discussion items to the District Director within 30 days. The overall inspection was classified as "No Action Indicated".