Company
BelgiumGenzyme Flanders, Geel, Belgium – FDA Inspections
Inspection records and compliance data for Genzyme Flanders in Geel. 10 FDA inspections on record, 2 Form 483s, last inspected November 07, 2025.
Company Profile
This profile covers Genzyme Flanders based in Geel, Belgium.
FDA Inspection History
- FDA inspections
- 10
- OAI
- 0
- VAI
- 3
- NAI
- 5
- Unclassified
- 2
- Form 483s
- 2
- Warning letters
- 0
First inspected October 27, 2011. Last inspected November 7, 2025.
FDA inspections (10)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| November 7, 2025 | Not classified | Biologics | 1290964 |
| February 15, 2022 | NAI | Human Drugs · Drug Quality Assurance | 1165725 |
| September 28, 2018 | Not classified | Human Drugs | 1077100 |
| March 23, 2018 | NAI | Human Drugs · Drug Quality Assurance | 1049261 |
| August 30, 2016 | NAI | Human Drugs · Drug Quality Assurance | 983432 |
| March 22, 2016 | NAI | Human Drugs · Drug Quality Assurance | 975606 |
| September 22, 2014 | NAI | Human Drugs · Drug Quality Assurance | 896914 |
| November 22, 2013 | VAI | Human Drugs · Drug Quality Assurance | 857679 |
| January 24, 2012 | VAI | Human Drugs · Drug Quality Assurance | 771754 |
| October 27, 2011 | VAI | Human Drugs · Drug Quality Assurance | 752272 |
FDA documents
Form 483s (1)
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Company Information
Name
Genzyme Flanders
FEI Number
3003623839
Address
Cipalstraat 8, Geel, Belgium
Country
Belgium
ID: 5f71d574-8097-4cd8-9254-2f8b85700e59