FDA Inspection
Bien-Air Surgery SABien-Air Surgery SA – FDA Inspection, Feb 16, 2023
Record Details
This FDA Inspection record concerns Bien-Air Surgery SA, with an inspection on February 16, 2023, issued by the Center for Devices and Radiological Health, covering devices.
View Company Profile
ID · d8b01cd5-a25f-41fb-a8b6-081e3eb61bda
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1198001
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 803.50(a)(2)Individual Report of Malfunction
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Bien-Air Surgery SA
2| Date | Classification | Office | Project area |
|---|---|---|---|
| August 30, 2018 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| September 6, 2012 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Bien-Air Surgery SA
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.