FDA Inspection 711939 — Cogentix Medical, Inc.
The FDA completed an inspection of Cogentix Medical, Inc. on Feb 11, 2011 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). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Feb 11, 2011
- Fiscal Year
- 2011
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Orangeburg, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14720 | 21 CFR 820.50(a)(3) | Acceptable supplier records, inadequate records |
| 14722 | 21 CFR 820.40 | Procedures not adequately established or maintained |
| 2630 | 21 CFR 820.30(e) | Design review - documentation |
| 3118 | 21 CFR 820.75(a) | Documentation |