FDA Inspection
Zhejiang Cheng Yi Pharmaceutical Co., Ltd.Zhejiang Cheng Yi Pharmaceutical Co., Ltd. – FDA Inspection, Nov 22, 2019
Record Details
This FDA Inspection record concerns Zhejiang Cheng Yi Pharmaceutical Co., Ltd., with an inspection on November 22, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- November 22, 2019
- Product Type
- Drugs
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ID · 3f7e8a81-98dc-42f2-beea-10147a0b6609
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1111465
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
4- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.142(b)Storage under appropriate conditions
- 21 CFR 211.22(a)Authority lacking to review records, investigate errors
- 21 CFR 211.100(a)Approval and review of procedures
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Other FDA inspections of Zhejiang Cheng Yi Pharmaceutical Co., Ltd.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| March 7, 2025 | Not classified | Office of Inspections and Investigations | |
| July 15, 2016 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 14, 2014 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 9, 2010 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Zhejiang Cheng Yi Pharmaceutical Co., Ltd.
- FDA Inspection 1265837 - 2025-03-07
- FDA Inspection 985172 - 2016-07-15
- FDA Inspection 879798 - 2014-03-14
- FDA Inspection 701018 - 2010-09-09
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