FDA Inspection
AeroBiotix USAAeroBiotix USA – FDA Inspection, Nov 14, 2018
Record Details
This FDA Inspection record concerns AeroBiotix USA, with an inspection on November 14, 2018, issued by the Center for Devices and Radiological Health, covering devices.
- Person
- Teresa K. Kastner
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ID · d0b29a99-eead-40bc-94ac-4c17aa3b62cc
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1071611
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.30(j)Design history file
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of AeroBiotix USA
3| Date | Classification | Office | Project area |
|---|---|---|---|
| October 1, 2026 | Not classified | Cincinnati District Office | |
| April 11, 2024 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 9, 2022 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for AeroBiotix USA
- FDA Inspection 1340344 - 2026-10-01
- FDA Inspection 1235713 - 2024-04-11
- FDA Inspection 1164057 - 2022-03-09
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