FDA Inspection
Rohto Pharmaceutical Co., Ltd. (Ueno Plant)Rohto Pharmaceutical Co., Ltd. (Ueno Plant) – FDA Inspection, Mar 8, 2023
Record Details
This FDA Inspection record concerns Rohto Pharmaceutical Co., Ltd. (Ueno Plant), with an inspection on March 8, 2023, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · ae514ac8-48dc-4350-8021-3971d423b3f5
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1202841
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
Other FDA inspections of Rohto Pharmaceutical Co., Ltd. (Ueno Plant)
3| Date | Classification | Office | Project area |
|---|---|---|---|
| March 2, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| November 14, 2014 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| November 20, 2012 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Rohto Pharmaceutical Co., Ltd. (Ueno Plant)
- FDA Inspection 1046964 - 2018-03-02
- FDA Inspection 906095 - 2014-11-14
- FDA Inspection 812116 - 2012-11-20
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