FDA Inspection
Hoffmann La Roche IncHoffmann La Roche Inc – FDA Inspection, Feb 4, 2011
Record Details
This FDA Inspection record concerns Hoffmann La Roche Inc, with an inspection on February 4, 2011, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Hoffmann La Roche Inc
- Inspection Date
- February 4, 2011
- Product Type
- Drugs
View Company Profile
ID · ec1e54cd-d261-44b2-bbdf-06ee2ea740b9
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 708141
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
2- 21 CFR 211.192Extent of discrepancy, failure investigations
- 21 CFR 211.170(b)Annual visual exams of drug products
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Other FDA inspections of Hoffmann La Roche Inc
3| Date | Classification | Office | Project area |
|---|---|---|---|
| July 8, 2011 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| December 2, 2010 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| August 18, 2009 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Hoffmann La Roche Inc
- FDA Inspection 735520 - 2011-07-08
- FDA Inspection 700072 - 2010-12-02
- FDA Inspection 605373 - 2009-08-18
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