FDA Inspection 674490 — Accutron Inc
The FDA completed an inspection of Accutron Inc on July 21, 2010 in Phoenix, AZ. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- July 21, 2010
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Phoenix, AZ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14712 | 21 CFR 820.184 | DHR - not or inadequately maintained |
| 3696 | 21 CFR 820.100(b) | Documentation |
| 4191 | 21 CFR 806.10(a)(1) | Report of risk to health |