FDA Inspection
Huzhou Arthur Pharmaceutical Co., Ltd.Huzhou Arthur Pharmaceutical Co., Ltd. – FDA Inspection, Sep 23, 2025
Record Details
This FDA Inspection record concerns Huzhou Arthur Pharmaceutical Co., Ltd., with an inspection on September 23, 2025, issued by the Office of Inspections and Investigations, covering human drugs.
- Inspection Date
- September 23, 2025
- Product Type
- Human Drugs
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ID · 4efc787d-b1ad-4212-80ab-00e032c789cf
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1288564
- FDA center
- Human Drugs
- Project area
- Generic Drug Evaluation
FDA Citations
3- 21 CFR 211.113(b)Validation lacking for sterile drug products
- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
- 21 CFR 211.42(c)(10)(v)Cleaning System
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Other FDA inspections of Huzhou Arthur Pharmaceutical Co., Ltd.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| September 22, 2026 | Not classified | Office of Inspections and Investigations | |
| June 19, 2026 | Not classified | Office of Inspections and Investigations |
Other documents for Huzhou Arthur Pharmaceutical Co., Ltd.
- FDA Inspection 1337514 - 2026-09-22
- FDA Inspection 1328918 - 2026-06-19
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