Company
FranceCousin Biotech SAS, Wervicq-Sud, France – FDA Inspections
Inspection records and compliance data for Cousin Biotech SAS in Wervicq-Sud. 4 FDA inspections on record (1 OAI), 1 Form 483, last inspected April 03, 2025.
Company Profile
This profile covers Cousin Biotech SAS based in Wervicq-Sud, France.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 1
- VAI
- 2
- NAI
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected May 25, 2011. Last inspected April 3, 2025.
Most cited issue areas
- Lack of or inadequate process validation2 inspections
- Design review - Lack of or inadequate procedures1 inspection
- Lack of or inadequate complaint procedures1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| April 3, 2025 | VAI | Medical Devices & Rad Health · Compliance: Medical Devices | 1267763 |
| September 17, 2015 | OAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 945588 |
| June 12, 2013 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 840547 |
| May 25, 2011 | VAI | Medical Devices & Rad Health · Compliance: Devices | 725872 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Cousin Biotech SAS
FEI Number
3003258310
Address
Allee des Roses, Wervicq-Sud, France
Country
France
ID: 43d67a33-58ef-4559-81df-49f6b899807c