FDA Inspection
Genzyme CorporationGenzyme Corporation – FDA Inspection, Oct 20, 2008
Record Details
This FDA Inspection record concerns Genzyme Corporation, with an inspection on October 20, 2008, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Genzyme Corporation
- Inspection Date
- October 20, 2008
- Product Type
- Drugs
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ID · f2cb68c3-f5bb-4916-953a-0ad1b0bbb5d6
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 543397
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
FDA Citations
2- 21 CFR 312.56(b)Investigator non-compliance
- 21 CFR 312.50General responsibilities of sponsors
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Other FDA inspections of Genzyme Corporation
8| Date | Classification | Office | Project area |
|---|---|---|---|
| August 10, 2016 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| August 22, 2014 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| March 25, 2014 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| September 30, 2013 | VAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| October 5, 2012 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
Other documents for Genzyme Corporation
- FDA Inspection 984314 - 2016-08-10
- FDA Inspection 892536 - 2014-08-22
- FDA Inspection 872528 - 2014-03-25
- FDA Inspection 850536 - 2013-09-30
- FDA Inspection 803799 - 2012-10-05
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