FDA Inspection 1003245 — Nikao, Inc.
The FDA completed an inspection of Nikao, Inc. on Feb 1, 2017 in Weston, FL. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI)
- End Date
- Feb 1, 2017
- Fiscal Year
- 2017
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Weston, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3686 | 21 CFR 820.90(b)(2) | Product rework documentation, DHR {see also 820.184} |