FDA Inspection 890802 — Cogentix Medical, Inc.
The FDA completed an inspection of Cogentix Medical, Inc. on Aug 8, 2014 in Orangeburg, NY. 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
- Aug 8, 2014
- Fiscal Year
- 2014
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Orangeburg, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3331 | 21 CFR 820.181 | DMR - not or inadequately maintained |
| 3686 | 21 CFR 820.90(b)(2) | Product rework documentation, DHR {see also 820.184} |