Company
United StatesGenzyme Corporation, Cambridge, MA – FDA Inspections
Inspection records and compliance data for Genzyme Corporation in Cambridge, Massachusetts. 9 FDA inspections on record, last inspected August 10, 2016.
Company Profile
This profile covers Genzyme Corporation based in Cambridge, Massachusetts, United States.
FDA Inspection History
- FDA inspections
- 9
- OAI
- 0
- VAI
- 4
- NAI
- 5
- Form 483s
- 0
- Warning letters
- 0
First inspected October 20, 2008. Last inspected August 10, 2016.
Most cited issue areas
- Failure by applicant to report ADE1 inspection
- Failure to meet specifications1 inspection
- General responsibilities of sponsors1 inspection
FDA inspections (9)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| August 10, 2016 | NAI | Human Drugs · Bioresearch Monitoring | 984314 |
| August 22, 2014 | NAI | Human Drugs · Bioresearch Monitoring | 892536 |
| March 25, 2014 | NAI | Human Drugs · Bioresearch Monitoring | 872528 |
| September 30, 2013 | VAI | Human Drugs · Bioresearch Monitoring | 850536 |
| October 5, 2012 | NAI | Human Drugs · Bioresearch Monitoring | 803799 |
| June 28, 2011 | VAI | Human Drugs · Drug Quality Assurance | 733818 |
| June 2, 2010 | VAI | Human Drugs · Bioresearch Monitoring | 666212 |
| September 9, 2009 | NAI | Medical Devices & Rad Health · Bioresearch Monitoring | 612169 |
| October 20, 2008 | VAI | Human Drugs · Bioresearch Monitoring | 543397 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Genzyme Corporation
FEI Number
1221955
Address
500 Kendall St, Cambridge, Massachusetts 02142, United States
Country
United States
ID: fbd6dd21-53c1-41bc-b851-8485fefaa640