FDA Inspection 985365 — Control Bionics

Control Bionics — FEI 3006789226

The FDA completed an inspection of Control Bionics on September 8, 2016 in Milford, OH. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 1 citation was issued during this inspection. Product area: Devices.

Inspection Details

Classification
No Action Indicated (NAI) (NAI)
End Date
September 8, 2016
Fiscal Year
2016
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Milford, OH (United States)

Citations

IDCFRDescription
312521 CFR 820.80(d)Lack of or inadequate final acceptance procedures