FDA Inspection 831310 — Cogentix Medical, Inc.
The FDA completed an inspection of Cogentix Medical, Inc. on May 1, 2013 in Orangeburg, NY. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- May 1, 2013
- Fiscal Year
- 2013
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Orangeburg, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3101 | 21 CFR 820.30(g) | Design validation- Lack of or inadequate procedures |
| 3696 | 21 CFR 820.100(b) | Documentation |