FDA Inspection 954923 — ACUTE Innovations LLC
The FDA completed an inspection of ACUTE Innovations LLC on January 28, 2016 in Hillsboro, OR. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- January 28, 2016
- Fiscal Year
- 2016
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Hillsboro, OR (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3118 | 21 CFR 820.75(a) | Documentation |
| 3837 | 21 CFR 820.25(b) | Training records |