FDA Inspection
Ono Pharmaceutical Co., Ltd.Ono Pharmaceutical Co., Ltd. – FDA Inspection, Dec 21, 2018
Record Details
This FDA Inspection record concerns Ono Pharmaceutical Co., Ltd., with an inspection on December 21, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 374bedd2-22cf-4e2e-a303-de35ab990672
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1079614
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
Other FDA inspections of Ono Pharmaceutical Co., Ltd.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| June 27, 2025 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| January 30, 2014 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Ono Pharmaceutical Co., Ltd.
- FDA Inspection 1277221 - 2025-06-27
- FDA Inspection 866877 - 2014-01-30
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