FDA Inspection
Cousin Biotech SASCousin Biotech SAS – FDA Inspection, Sep 17, 2015
Record Details
This FDA Inspection record concerns Cousin Biotech SAS, with an inspection on September 17, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Cousin Biotech SAS
- Inspection Date
- September 17, 2015
- Product Type
- Devices
View Company Profile
ID · 47d6a934-2562-414a-8cab-1480425eca45
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 945588
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
5- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(e)Design review - Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 803.17(a)(1)Lack of System for Event Evaluations
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Cousin Biotech SAS
3| Date | Classification | Office | Project area |
|---|---|---|---|
| April 3, 2025 | VAI | Office of Inspections and Investigations | Compliance: Medical 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 1267763 - 2025-04-03
- FDA Inspection 840547 - 2013-06-12
- FDA Inspection 725872 - 2011-05-25
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