FDA Inspection
Anhui Hanbon Daily Chemical Co., Ltd.Anhui Hanbon Daily Chemical Co., Ltd. – FDA Inspection, Feb 28, 2025
Record Details
This FDA Inspection record concerns Anhui Hanbon Daily Chemical Co., Ltd., with an inspection on February 28, 2025, issued by the Office of Inspections and Investigations, covering human drugs.
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ID · a7e34940-6492-4c19-b48a-0cdc6533b4ee
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1264612
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
6- 21 CFR 211.166(b)Adequate number of batches on stability
- 21 CFR 211.84(d)(1)Component identity verification
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.165(e)Test methods
- 21 CFR 211.180(e)(1)Review of representative number of batches
- 21 CFR 211.100(a)Absence of Written Procedures
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