FDA Inspection 832321 — Nikao, Inc.

Nikao, Inc. — FEI 3005687068

The FDA completed an inspection of Nikao, Inc. on May 13, 2013 in Weston, FL. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 3 citations were issued during this inspection. Product area: Devices.

Inspection Details

Classification
No Action Indicated (NAI)
End Date
May 13, 2013
Fiscal Year
2013
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Weston, FL (United States)

Citations

IDCFRDescription
235021 CFR 820.25(b)Training - Lack of or inadequate procedures
313021 CFR 820.100(a)Lack of or inadequate procedures
328221 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures