FDA 483 - CHRI Laboratories, Inc. - June 14, 2022

CHRI Laboratories, Inc. in Saint Paul, MN, a control testing laboratory, was cited for significant deficiencies in its quality control unit, testing method verification, instrument calibration, and personnel qualifications. The inspection revealed issues including inadequate training, a lapse in the QA Leader's contract, data integrity concerns with unvalidated systems, and a shortage of qualified staff for critical testing. These observations indicate a systemic breakdown in quality management and operational control.