FDA Inspection
Shanghai Aucyun Pharmaceuticals Co., LtdShanghai Aucyun Pharmaceuticals Co., Ltd – FDA Inspection, Aug 31, 2023
Record Details
This FDA Inspection record concerns Shanghai Aucyun Pharmaceuticals Co., Ltd, with an inspection on August 31, 2023, issued by the Office of Inspections and Investigations.
- Inspection Date
- August 31, 2023
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ID · 763e3767-8130-4b4c-94ea-4c7252e218f7
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1218136
- FDA center
- Human Drugs
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 211.142(b)Storage under appropriate conditions
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.67(b)Written procedures not established/followed
- 21 CFR 211.80(a)Procedures To Be in Writing
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Other FDA inspections of Shanghai Aucyun Pharmaceuticals Co., Ltd
1| Date | Classification | Office | Project area |
|---|---|---|---|
| November 7, 2025 | Not classified | Office of Inspections and Investigations |
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