FDA 483 - EuTech Scientific Services Inc - December 28, 2021

An FDA inspection of EuTech Scientific Services Inc, a control testing laboratory in Highland Park, NJ, revealed significant deficiencies in laboratory control mechanisms and quality control unit oversight. The firm failed to consistently follow and document established test procedures, maintain control over test sheets and notebooks, and ensure data integrity. Additionally, the quality control unit lacked adequate authority to review electronic data, conduct thorough investigations, and approve equipment calibration records.