FDA Inspection 1047161 — DNE LLC
The FDA completed an inspection of DNE LLC on Apr 6, 2018 in Boca Raton, FL. 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 6, 2018
- Fiscal Year
- 2018
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Boca Raton, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3415 | 21 CFR 820.22 | Quality Audit/Reaudit - conducted |
| 632 | 21 CFR 803.17(a)(2) | Lack of System for Determining MDR Events |