FDA Inspection 828035 — ACUTE Innovations LLC
The FDA completed an inspection of ACUTE Innovations LLC on Apr 19, 2013 in Hillsboro, OR. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Apr 19, 2013
- Fiscal Year
- 2013
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Hillsboro, OR (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3237 | 21 CFR 820.72(b) | Remedial action |
| 3375 | 21 CFR 820.198(e) | Records of complaint investigation |