FDA Inspection
Mitsubishi Tanabe Pharma Factory Ltd.Mitsubishi Tanabe Pharma Factory Ltd. – FDA Inspection, Dec 11, 2015
Record Details
This FDA Inspection record concerns Mitsubishi Tanabe Pharma Factory Ltd., with an inspection on December 11, 2015, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- December 11, 2015
- Product Type
- Drugs
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ID · 93c3c787-b3f0-4361-b7ba-929ce63ce773
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 950893
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
3- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.63Equipment Design, Size and Location
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Other FDA inspections of Mitsubishi Tanabe Pharma Factory Ltd.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| January 19, 2024 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 22, 2017 | Not classified | Office of Inspections and Investigations | |
| November 3, 2011 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Mitsubishi Tanabe Pharma Factory Ltd.
- FDA Inspection 1228573 - 2024-01-19
- FDA Inspection 1028432 - 2017-09-22
- FDA Inspection 752836 - 2011-11-03
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