FDA EIR - Charles River Laboratories, Inc. - November 09, 2018

Charles River Laboratories' Shrewsbury facility underwent an FDA inspection from November 5-9, 2018, specifically targeting its Biologic Testing Solution group's current Good Manufacturing Practice (cGMP) operations. This initial cGMP inspection for the unit, which provides biological and bioanalytical services to the pharmaceutical industry, was conducted under Compliance Program 7356.002 for Drug Manufacturing. While no formal FDA Form 483 "Inspectional Observations" was issued, several key concerns were discussed with management. These included insufficient documentation of corrective and preventative actions (CAPAs) in deviation investigations and a lack of comparative data evaluation when transferring analytical methods between sites. Additionally, it was noted that methods were sometimes made effective prior to the full completion and approval of their validation activities. The company's management acknowledged these issues and committed to evaluating them for appropriate action.