961411
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- November 25, 2015
- Fiscal Year
- 2016
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Allendale, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3192 | 21 CFR 820.30(g) | Design validation - user needs and intended uses |
| 4192 | 21 CFR 806.10(a)(2) | Report of violation of the Act (see 803.52(e)(9)) |