FDA Inspection 1167401 — Cogentix Medical, Inc.

Cogentix Medical, Inc. — FEI 2242464

The FDA completed an inspection of Cogentix Medical, Inc. on Apr 14, 2022 in Orangeburg, NY. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 1 citation was issued during this inspection. Product area: Devices.

Inspection Details

Classification
No Action Indicated (NAI)
End Date
Apr 14, 2022
Fiscal Year
2022
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Orangeburg, NY (United States)

Citations

IDCFRDescription
1471221 CFR 820.184DHR - not or inadequately maintained