FDA Inspection
Shionogi Pharma Co., Ltd.Shionogi Pharma Co., Ltd. – FDA Inspection, Jun 3, 2016
Record Details
This FDA Inspection record concerns Shionogi Pharma Co., Ltd., with an inspection on June 3, 2016, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Shionogi Pharma Co., Ltd.
- Inspection Date
- June 3, 2016
- Product Type
- Drugs
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ID · f855dc7a-5816-45c0-ae6a-9188dc5033f5
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 974314
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
5- 21 CFR 211.22(b)Adequate lab facilities not available
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.192Extent of discrepancy, failure investigations
- 21 CFR 211.194(a)Complete test data included in records
- 21 CFR 211.166(a)(3)Valid stability test methods
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Other FDA inspections of Shionogi Pharma Co., Ltd.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| April 5, 2024 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 15, 2012 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 15, 2012 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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