FDA Inspection
CSPC Ouyi Pharmaceutical Co., Ltd.CSPC Ouyi Pharmaceutical Co., Ltd. – FDA Inspection, Jun 15, 2018
Record Details
This FDA Inspection record concerns CSPC Ouyi Pharmaceutical Co., Ltd., with an inspection on June 15, 2018, issued by the Office of Inspections and Investigations, covering human drugs.
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ID · 5d79b23d-2a17-4f80-ba0f-e2cd89c1837b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1058543
- FDA center
- Human Drugs
- Project area
- Generic Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
- 21 CFR 211.67(b)Written procedures fail to include
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Other FDA inspections of CSPC Ouyi Pharmaceutical Co., Ltd.
9| Date | Classification | Office | Project area |
|---|---|---|---|
| September 5, 2024 | Not classified | Office of Inspections and Investigations | |
| May 17, 2019 | VAI | Office of Inspections and Investigations | Generic Drug Evaluation |
| October 20, 2017 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| August 2, 2017 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 25, 2015 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for CSPC Ouyi Pharmaceutical Co., Ltd.
- FDA Inspection 1239361 - 2024-09-05
- FDA Inspection 1091103 - 2019-05-17
- FDA Inspection 1036247 - 2017-10-20
- FDA Inspection 1021148 - 2017-08-02
- FDA Inspection 945964 - 2015-09-25
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