Company
SwitzerlandGexfix SA, Le Grand-Saconnex, Switzerland – FDA Inspections
Inspection records and compliance data for Gexfix SA in Le Grand-Saconnex. 3 FDA inspections on record (1 OAI), 1 Form 483, 1 warning letter, last inspected November 21, 2024.
Company Profile
This profile covers Gexfix SA based in Le Grand-Saconnex, Switzerland.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 1
- VAI
- 1
- NAI
- 1
- Form 483s
- 1
- Warning letters
- 1
First inspected January 16, 2013. Last inspected November 21, 2024.
Most cited issue areas
- Design validation - user needs and intended uses1 inspection
- Lack of or inadequate procedures1 inspection
- Lack of or inadequate process validation1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| November 21, 2024 | VAI | Medical Devices & Rad Health · Compliance: Medical Devices | 1254674 |
| September 4, 2014 | NAI | Medical Devices & Rad Health · Compliance: Devices | 894203 |
| January 16, 2013 | OAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 820118 |
FDA documents
Warning Letters (1)
People (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Gexfix SA
FEI Number
3005157180
Address
Le Grand-Saconnex, Chemin Du Pavillon 2, Le Grand-Saconnex, Switzerland
Country
Switzerland
ID: bb840f7c-a26a-49d5-a92a-1d5186088879