FDA Inspection
Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd.Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd. – FDA Inspection, Sep 10, 2019
Record Details
This FDA Inspection record concerns Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd., with an inspection on September 10, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- September 10, 2019
- Product Type
- Drugs
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ID · fffa5f62-5ff7-461b-9118-e485bdad04e8
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1106423
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
Other FDA inspections of Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd.
6| Date | Classification | Office | Project area |
|---|---|---|---|
| March 22, 2024 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 23, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 12, 2016 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 26, 2014 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| July 9, 2012 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd.
- FDA Inspection 1230640 - 2024-03-22
- FDA Inspection 1049653 - 2018-03-23
- FDA Inspection 958528 - 2016-02-12
- FDA Inspection 888415 - 2014-06-26
- FDA Inspection 801261 - 2012-07-09
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