FDA Inspection
Tokuhon Corporation Miyashiro FactoryTokuhon Corporation Miyashiro Factory – FDA Inspection, Nov 4, 2016
Record Details
This FDA Inspection record concerns Tokuhon Corporation Miyashiro Factory, with an inspection on November 4, 2016, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · d5a09f86-2792-41d5-838b-e0cfa8c0a97c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 995997
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 211.100(a)Changes to Procedures Not Reviewed, Approved
- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.160(b)Scientifically sound laboratory controls
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Other FDA inspections of Tokuhon Corporation Miyashiro Factory
1| Date | Classification | Office | Project area |
|---|---|---|---|
| September 23, 2011 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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