FDA Inspection
Bien-Air Surgery SABien-Air Surgery SA – FDA Inspection, Aug 30, 2018
Record Details
This FDA Inspection record concerns Bien-Air Surgery SA, with an inspection on August 30, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · bbcca4e2-62e9-40e5-93c7-26d7343be331
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1063812
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.72(b)Remedial action
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Other FDA inspections of Bien-Air Surgery SA
2| Date | Classification | Office | Project area |
|---|---|---|---|
| February 16, 2023 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| September 6, 2012 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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