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

Source: https://www.globalkeysolutions.net/records/483/center-for-instrumental-analysis-of-china-pharmaceutical-university/574d5a56-1b25-4288-ab7b-79e11ef2c58a

> FDA 483 for Center for Instrumental Analysis of China Pharmaceutical University on September 20, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Center for Instrumental Analysis of China Pharmaceutical University
- Inspection Date: 2024-09-20
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: 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.

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Company: https://www.globalkeysolutions.net/companies/center-for-instrumental-analysis-of-china-pharmaceutical-university/7101e1d9-9c46-4d12-a771-ec9dc8879bd6

Office: https://www.globalkeysolutions.net/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1