FDA 483 - Center for Instrumental Analysis of China Pharmaceutical University - September 20, 2024
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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.
- Inspection Date
- September 20, 2024
- Product Type
- Drugs
ID · 574d5a56-1b25-4288-ab7b-79e11ef2c58a