FDA 483 - Charles River Laboratories Ireland Ltd. - October 18, 2019

An FDA inspection of Charles River Laboratories Ireland Ltd. in Ballina, Co. Mayo, a contract testing laboratory, revealed significant deficiencies in laboratory controls and equipment management. Observations included inadequate sterility testing procedures, lack of data integrity controls for computer systems and balances, and the use of uncalibrated pH meters for critical measurements. These issues indicate a failure to ensure drug product quality and data reliability.