FDA EIR - CHARLES RIVER LABORATORIES - August 03, 2018

An FDA Good Laboratory Practice (GLP) surveillance inspection was conducted at Charles River Laboratories Ashland LLC from July 23 to August 3, 2018. This inspection, operating under Compliance Program 7348.808, aimed to ensure compliance with regulations for nonclinical laboratory studies. While no FDA Form 483 was issued, several observations were discussed with management. Key issues included one undocumented protocol deviation and five instances of non-compliance with Standard Operating Procedures (SOPs) associated with study protocols. Specific concerns involved identified dosing errors in a final study report, inaccurate documentation regarding serviced water systems, improper storage of inventory in the general receiving area, and inadequate labeling of large ice containers in chemistry areas. Additionally, SOP non-compliance was noted for not documenting exposure times during a specific examination phase of a study. Management was highly cooperative, took immediate corrective actions, and committed to formally responding to all discussed items.