FDA Inspection 1164057 — AeroBiotix USA
The FDA completed an inspection of AeroBiotix USA on Mar 9, 2022 in Miamisburg, OH. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI)
- End Date
- Mar 9, 2022
- Fiscal Year
- 2022
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Miamisburg, OH (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3677 | 21 CFR 820.30(g) | Design validation - software validation not performed |
| 502 | 21 CFR 820.60 | Identification procedures, Lack of or inadequate procedures |