FDA Inspection
Kyowa Hakko Bio Co. Ltd.Kyowa Hakko Bio Co. Ltd. – FDA Inspection, Sep 15, 2017
Record Details
This FDA Inspection record concerns Kyowa Hakko Bio Co. Ltd., with an inspection on September 15, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 274c4990-3600-44d7-bc36-7b1584231e09
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1026240
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
Other FDA inspections of Kyowa Hakko Bio Co. Ltd.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| November 8, 2019 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 14, 2014 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| July 2, 2010 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Kyowa Hakko Bio Co. Ltd.
- FDA Inspection 1113169 - 2019-11-08
- FDA Inspection 873176 - 2014-03-14
- FDA Inspection 675346 - 2010-07-02
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