FDA 483 - Charles River Laboratories, Inc. - June 21, 2017

Charles River Laboratories Inc. in Wilmington, MA, a contract testing laboratory, was cited for multiple deficiencies during an FDA inspection. Observations included inadequate laboratory facilities with persistent humidity control issues, unapproved changes to laboratory control mechanisms, and failure to follow equipment cleaning procedures. Additionally, the firm experienced lapses in quality control unit responsibilities, including staff training for monitoring equipment, and maintained unsanitary conditions in animal housing facilities.