FDA Inspection
Morishita Jintan Co., Ltd.Morishita Jintan Co., Ltd. – FDA Inspection, May 19, 2023
Record Details
This FDA Inspection record concerns Morishita Jintan Co., Ltd., with an inspection on May 19, 2023, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · fa7dae60-b969-43b4-8532-43cb76a8deb0
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1207312
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.166(c)(2)Homeopathic drugs, same container - closure
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.166(c)(2)Homeopathic drugs, same container - closure
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Other FDA inspections of Morishita Jintan Co., Ltd.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| November 30, 2018 | NAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| November 7, 2012 | NAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| February 3, 2012 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Morishita Jintan Co., Ltd.
- FDA Inspection 1088942 - 2018-11-30
- FDA Inspection 808340 - 2012-11-07
- FDA Inspection 785570 - 2012-02-03
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