FDA Inspection
China Pharmaceutical UniversityFDA Inspection 1249754 - China Pharmaceutical University - September 20, 2024
Record Details
This FDA Inspection record concerns China Pharmaceutical University, with an inspection on September 20, 2024, issued by the Office of Inspections and Investigations, covering human drugs.
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ID · d607a7ef-4da4-4798-81e3-660ab120bf74
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1249754
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
7- 21 CFR 211.68(b)Computer control of master formula records
- 21 CFR 211.25(a)Training , Education , Experience overall
- 21 CFR 211.194(a)Complete test data included in records
- 21 CFR 211.194(d)Laboratory equipment calibration records
- 21 CFR 211.180(c)Records not made readily available to FDA
- 21 CFR 211.160(a)Lab controls established, including changes
- 21 CFR 211.22(a)Lack of quality control unit
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