FDA Inspection
Cousin Biotech SASCousin Biotech SAS – FDA Inspection, Apr 3, 2025
Record Details
This FDA Inspection record concerns Cousin Biotech SAS, with an inspection on April 3, 2025, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
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ID · 18456377-284c-4b6b-8391-a141efc8fb11
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1267763
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Medical Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.250(a)Statistical techniques - Lack of or inadequate procedures
- 21 CFR 820.75(a)Lack of or inadequate process validation
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Cousin Biotech SAS
3| Date | Classification | Office | Project area |
|---|---|---|---|
| September 17, 2015 | OAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| June 12, 2013 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| May 25, 2011 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Cousin Biotech SAS
- FDA Inspection 945588 - 2015-09-17
- FDA Inspection 840547 - 2013-06-12
- FDA Inspection 725872 - 2011-05-25
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