FDA Inspection
Daiichi Sankyo Co., Ltd. Hiratsuka PlantDaiichi Sankyo Co., Ltd. Hiratsuka Plant – FDA Inspection, Nov 2, 2017
Record Details
This FDA Inspection record concerns Daiichi Sankyo Co., Ltd. Hiratsuka Plant, with an inspection on November 2, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 9070c8d4-53c7-4b95-bbd3-84d004ef030b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1032011
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 211.160(a)Following/documenting laboratory controls
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.192Written record of investigation incomplete
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Other FDA inspections of Daiichi Sankyo Co., Ltd. Hiratsuka Plant
3| Date | Classification | Office | Project area |
|---|---|---|---|
| August 29, 2019 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| April 22, 2016 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 13, 2014 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Daiichi Sankyo Co., Ltd. Hiratsuka Plant
- FDA Inspection 1105205 - 2019-08-29
- FDA Inspection 971651 - 2016-04-22
- FDA Inspection 888923 - 2014-06-13
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