FDA Inspection
Roche Pharma AGRoche Pharma AG – FDA Inspection, Nov 25, 2016
Record Details
This FDA Inspection record concerns Roche Pharma AG, with an inspection on November 25, 2016, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 8f393e9d-2081-4fd4-bb59-4d8772697592
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 996367
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 211.160(a)Following/documenting laboratory controls
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.198(b)(2)Written record of complaint to include findings, follow-up
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Other FDA inspections of Roche Pharma AG
2| Date | Classification | Office | Project area |
|---|---|---|---|
| December 2, 2014 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 21, 2011 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Roche Pharma AG
- FDA Inspection 908975 - 2014-12-02
- FDA Inspection 750829 - 2011-09-21
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