FDA Inspection 905359 — Inovo, Inc
The FDA completed an inspection of Inovo, Inc on Nov 19, 2014 in Lehigh Acres, FL. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 10 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Nov 19, 2014
- Fiscal Year
- 2015
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Lehigh Acres, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 2327 | 21 CFR 820.22 | Quality audits - Lack of or inadequate procedures |
| 2350 | 21 CFR 820.25(b) | Training - Lack of or inadequate procedures |
| 3101 | 21 CFR 820.30(g) | Design validation- Lack of or inadequate procedures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3375 | 21 CFR 820.198(e) | Records of complaint investigation |
| 3677 | 21 CFR 820.30(g) | Design validation - software validation not performed |
| 3678 | 21 CFR 820.30(g) | Design Validation - Risk analysis not performed/inadequate |
| 479 | 21 CFR 820.50 | Purchasing controls, Lack of or inadequate procedures |
| 541 | 21 CFR 820.70(c) | Environmental control Lack of or inadequate procedures |