FDA Inspection
Chang Kuo Chou Pharmaceutical Co., Ltd.Chang Kuo Chou Pharmaceutical Co., Ltd. – FDA Inspection, Sep 8, 2017
Record Details
This FDA Inspection record concerns Chang Kuo Chou Pharmaceutical Co., Ltd., with an inspection on September 8, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · e7a9f452-cede-4dac-98aa-4a9f9539113e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1027537
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 211.100(b)SOPs not followed / documented
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Other FDA inspections of Chang Kuo Chou Pharmaceutical Co., Ltd.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| July 21, 2023 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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