FDA Inspection
Rohto Pharmaceutical Co., Ltd. (Ueno Plant)Rohto Pharmaceutical Co., Ltd. (Ueno Plant) – FDA Inspection, Nov 14, 2014
Record Details
This FDA Inspection record concerns Rohto Pharmaceutical Co., Ltd. (Ueno Plant), with an inspection on November 14, 2014, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- November 14, 2014
- Product Type
- Drugs
View Company Profile
ID · 96dc1902-2cbe-4402-baa6-b53a59c3190f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 906095
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
10- 21 CFR 211.84(d)(2)Testing Each Component for Conformity with Specs
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.130(b)Unlabeled filled containers controls
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.134(a)Correct labels during finishing operations
- 21 CFR 211.165(e)Test methods
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.160(b)(1)Sampling and testing procedures described
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Other FDA inspections of Rohto Pharmaceutical Co., Ltd. (Ueno Plant)
3| Date | Classification | Office | Project area |
|---|---|---|---|
| March 8, 2023 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 2, 2018 | 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 1202841 - 2023-03-08
- FDA Inspection 1046964 - 2018-03-02
- FDA Inspection 812116 - 2012-11-20
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