FDA Inspection
Sanofi-Aventis US LLCSanofi-Aventis US LLC – FDA Inspection, Mar 14, 2012
Record Details
This FDA Inspection record concerns Sanofi-Aventis US LLC, with an inspection on March 14, 2012, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Sanofi-Aventis US LLC
- Inspection Date
- March 14, 2012
- Product Type
- Drugs
View Company Profile
ID · f27b2f6b-ea97-42bf-98e6-29f15a4640e5
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 772113
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
4- 21 CFR 211.100(a)Changes to Procedures Not Reviewed, Approved
- 21 CFR 211.150(a)Distribution of oldest stock first
- 21 CFR 211.80(a)Written Procedures Not Followed
- 21 CFR 211.100(b)SOPs not followed / documented
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Other FDA inspections of Sanofi-Aventis US LLC
4| Date | Classification | Office | Project area |
|---|---|---|---|
| June 2, 2017 | Not classified | Kansas City District Office | Drug Quality Assurance |
| February 12, 2014 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| October 6, 2010 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| January 28, 2009 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Sanofi-Aventis US LLC
- FDA Inspection 1012790 - 2017-06-02
- FDA Inspection 867881 - 2014-02-12
- FDA Inspection 684201 - 2010-10-06
- FDA Inspection 563141 - 2009-01-28
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