FDA 483 - Center for Instrumental Analysis of China Pharmaceutical University - September 20, 2024

The FDA inspected the Center for Instrumental Analysis of China Pharmaceutical University in Nanjing, China, a control testing laboratory. The inspection revealed significant deficiencies across its quality system, laboratory controls, and record-keeping practices, indicating a severe lack of fundamental GMP/GLP compliance. Key issues include the absence of a quality control unit, inadequate record retention, lack of employee training, and insufficient computer system controls.