FDA Inspection
VisionAir Solutions LLCVisionAir Solutions LLC – FDA Inspection, Mar 14, 2024
Record Details
This FDA Inspection record concerns VisionAir Solutions LLC, with an inspection on March 14, 2024, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 68e3fc39-ec43-4c26-82ea-c9721ca6076a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1233164
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
2- 21 CFR 820.75(b)Lack/Inad procedure-Monitoring/Control of Validated Proces
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of VisionAir Solutions LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| February 9, 2017 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| February 19, 2014 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for VisionAir Solutions LLC
- FDA Inspection 1003660 - 2017-02-09
- FDA Inspection 867399 - 2014-02-19
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