FDA Inspection
FujiFilm Ultra Pure Solutions, Inc.FujiFilm Ultra Pure Solutions, Inc. – FDA Inspection, Jan 12, 2017
Record Details
This FDA Inspection record concerns FujiFilm Ultra Pure Solutions, Inc., with an inspection on January 12, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 7882f518-e6a7-4848-afea-06a662f35a0a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 996404
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 211.58Buildings not maintained in good state of repair
- 21 CFR 211.165(e)Test methods
- 21 CFR 211.188(b)Batch production and Batch Control Record Requirements
- 21 CFR 211.22(a)Lack of quality control unit
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Other FDA inspections of FujiFilm Ultra Pure Solutions, Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| January 15, 2020 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 1, 2010 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for FujiFilm Ultra Pure Solutions, Inc.
- FDA Inspection 1116146 - 2020-01-15
- FDA Inspection 678306 - 2010-09-01
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