FDA Inspection
Genzyme CorporationGenzyme Corporation – FDA Inspection, Jun 2, 2010
Record Details
This FDA Inspection record concerns Genzyme Corporation, with an inspection on June 2, 2010, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Genzyme Corporation
- Inspection Date
- June 2, 2010
- Product Type
- Drugs
View Company Profile
ID · e9d58250-84e5-4972-b3d3-9c3f3363ddd3
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 666212
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
FDA Citations
5- 21 CFR 314.80(c)Failure by applicant to report ADE
- 21 CFR 314.81(b)(1)(ii)Failure to meet specifications
- 21 CFR 314.80(c)(1)(ii)Submission of report follow-up
- 21 CFR 314.80(c)(1)(i)Late submission of 15-day report
- 21 CFR 314.80(c)(2)Late submission of annual safety reports
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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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