FDA EIR - CHARLES RIVER LABORATORIES - July 16, 2021

Charles River Laboratories in Mattawan, MI, underwent an FDA inspection from July 12 to July 16, 2021. This comprehensive surveillance and complaint follow-up inspection was guided by the Good Laboratory Practices (GLP) regulatory framework, specifically 21 CFR Part 58, focusing on two non-clinical laboratory studies. While no formal FDA-483 (Inspectional Observations) was issued, five key discussion points were raised with management regarding facility operations and study conduct.

Main issues included the inappropriate storage of perishable supplies (such as Normal Saline and Sterile Water for Irrigation) in an unmonitored receiving area, not meeting required USP storage conditions. An incorrect feed lot was also documented for a canine study on one occasion. Environmental control deficiencies were noted, specifically three uninvestigated temperature excursions in an animal room over consecutive days, falling below the acceptable range for rodents. Additionally, documentation for two protocol deviations regarding sample processing lacked specific subject numbers, and two exterior doors had gaps allowing potential pest entry.

Voluntary corrections were promptly made during the inspection, including relocating the improperly stored products and repairing the door gaps. An amendment was initiated for the study report to reflect the feed lot documentation error. Management was requested to provide responses to the remaining issues, particularly the lack of investigation into the recurring temperature excursions and the completeness of deviation documentation.