FDA Inspection 955978 — Nico Corp.
The FDA completed an inspection of Nico Corp. on Dec 30, 2015 in Indianapolis, IN. 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). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Dec 30, 2015
- Fiscal Year
- 2016
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Indianapolis, IN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3101 | 21 CFR 820.30(g) | Design validation- Lack of or inadequate procedures |
| 3696 | 21 CFR 820.100(b) | Documentation |
| 4192 | 21 CFR 806.10(a)(2) | Report of violation of the Act (see 803.52(e)(9)) |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |