FDA Inspection
MicroBiopharm Japan Co., Ltd.MicroBiopharm Japan Co., Ltd. – FDA Inspection, Mar 16, 2018
Record Details
This FDA Inspection record concerns MicroBiopharm Japan Co., Ltd., with an inspection on March 16, 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 · 84aaeb95-d332-4774-9c54-e0fd4f39253e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1045597
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 211.166(a)(3)Valid stability test methods
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Other FDA inspections of MicroBiopharm Japan Co., Ltd.
5| Date | Classification | Office | Project area |
|---|---|---|---|
| February 13, 2026 | Not classified | Office of Inspections and Investigations | |
| September 13, 2019 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 17, 2016 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| December 21, 2012 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| October 7, 2009 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for MicroBiopharm Japan Co., Ltd.
- FDA Inspection 1310602 - 2026-02-13
- FDA Inspection 1101926 - 2019-09-13
- FDA Inspection 977165 - 2016-06-17
- FDA Inspection 813119 - 2012-12-21
- FDA Inspection 632846 - 2009-10-07
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