FDA Inspection
AeroBiotix USAAeroBiotix USA – FDA Inspection, Apr 11, 2024
Record Details
This FDA Inspection record concerns AeroBiotix USA, with an inspection on April 11, 2024, issued by the Center for Devices and Radiological Health, covering devices.
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ID · f9146a10-18ef-4705-9884-6ab0b3e2a56b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1235713
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.90(b)(2)Product rework documentation, DHR {see also 820.184}
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Other FDA inspections of AeroBiotix USA
3| Date | Classification | Office | Project area |
|---|---|---|---|
| October 1, 2026 | Not classified | Cincinnati District Office | |
| March 9, 2022 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| November 14, 2018 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for AeroBiotix USA
- FDA Inspection 1340344 - 2026-10-01
- FDA Inspection 1164057 - 2022-03-09
- FDA Inspection 1071611 - 2018-11-14
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