Cousin Biotech — FDA Facility Profile
Cousin Biotech is an FDA-registered facility (FEI 3003258310) located in WERVICQ-SUD Nord, FR. RegDataLab tracks 4 FDA inspections at this facility.
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What FDA found at this site
- Latest inspection
- Apr 3, 2025: Voluntary Action Indicated (VAI)
- Inspections on record
- 4 (1 OAI, 1 VAI, 2 NAI)
- Last OAI inspection
- Sep 17, 2015
- Warning letters
- None matched to this FEI. Many letters do not state an FEI: search warning letters by company name
- Import refusals
- 1
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| Apr 3, 2025 | Voluntary Action Indicated (VAI) | No citations listed |
| Sep 17, 2015 | Official Action Indicated (OAI) | Lack of or inadequate complaint procedures (21 CFR 820.198(a)) Design review - Lack of or inadequate procedures (21 CFR 820.30(e)) Lack of or inadequate procedures (21 CFR 820.100(a)) Lack of or inadequate process validation (21 CFR 820.75(a)) and 1 more |
| Jun 12, 2013 | No Action Indicated (NAI) | No citations listed |
| May 25, 2011 | No Action Indicated (NAI) | DMR - not or inadequately maintained (21 CFR 820.181) Process control procedures, Lack of or inadequate procedures (21 CFR 820.70(a)) |
Facility details
- Company
- Cousin Biotech SAS
- Location
- WERVICQ-SUD Nord (FR)
- Source
- device