FDA Inspection
Tomita Pharmaceutical Co., Ltd.Tomita Pharmaceutical Co., Ltd. – FDA Inspection, Mar 9, 2018
Record Details
This FDA Inspection record concerns Tomita Pharmaceutical Co., Ltd., with an inspection on March 9, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
- People
- Jason R. Caballero (FDA Associated Person)
- Vioela Respress (Issuing Officer)
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ID · c60f41d1-194c-40a9-b100-9e28bf1526c7
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1045598
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 211.58Buildings not maintained in good state of repair
- 21 CFR 211.165(b)Microbiological testing
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.42(c)(1)Incoming material area
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Other FDA inspections of Tomita Pharmaceutical Co., Ltd.
7| Date | Classification | Office | Project area |
|---|---|---|---|
| May 23, 2025 | Not classified | Office of Inspections and Investigations | |
| November 8, 2019 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| July 29, 2016 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| November 1, 2013 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| November 1, 2013 | VAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
Other documents for Tomita Pharmaceutical Co., Ltd.
- FDA Inspection 1274910 - 2025-05-23
- FDA Inspection 1113539 - 2019-11-08
- FDA Inspection 981352 - 2016-07-29
- FDA Inspection 860359 - 2013-11-01
- FDA Inspection 860351 - 2013-11-01
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