FDA Inspection 1164057 — AeroBiotix USA
The FDA completed an inspection of AeroBiotix USA on March 9, 2022 in Miamisburg, OH. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 9, 2022
- Fiscal Year
- 2022
- Product Type
- Devices
- Project Area
- Compliance: 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 |