FDA Inspection
Yangzhou Sion Commodity Co., Ltd.Yangzhou Sion Commodity Co., Ltd. – FDA Inspection, Jul 20, 2018
Record Details
This FDA Inspection record concerns Yangzhou Sion Commodity Co., Ltd., with an inspection on July 20, 2018, issued by the Office of Inspections and Investigations, covering human drugs.
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ID · e959fd28-675f-4fb2-954b-a5f0990cee1e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1065785
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 211.142(b)Storage under appropriate conditions
- 21 CFR 211.160(b)(4)Test devices not meeting specifications
- 21 CFR 211.166(a)Lack of written stability program
- 21 CFR 211.180(e)Records reviewed annually
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Other FDA inspections of Yangzhou Sion Commodity Co., Ltd.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| September 27, 2024 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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