Company
SwitzerlandBien-Air Surgery SA, Le Noirmont, Switzerland – FDA Inspections
Inspection records and compliance data for Bien-Air Surgery SA in Le Noirmont. 3 FDA inspections on record, 2 Form 483s, last inspected February 16, 2023.
Company Profile
This profile covers Bien-Air Surgery SA based in Le Noirmont, Switzerland.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 3
- NAI
- 0
- Form 483s
- 2
- Warning letters
- 0
First inspected September 6, 2012. Last inspected February 16, 2023.
Most cited issue areas
- Design input - documentation1 inspection
- Device identification, control numbers1 inspection
- Individual Report of Malfunction1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| February 16, 2023 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1198001 |
| August 30, 2018 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1063812 |
| September 6, 2012 | VAI | Medical Devices & Rad Health · Compliance: Devices | 803507 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Bien-Air Surgery SA
FEI Number
3003800209
Address
Rue De L'Ouest 2b, Le Noirmont, Switzerland
Country
Switzerland
ID: e1a90f17-f666-46d9-b390-5d8e0e78a5b9