FDA Inspection 581442 — Gaven Medical
The FDA completed an inspection of Gaven Medical on May 8, 2009 in Vernon, CT. 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
- May 8, 2009
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Vernon, CT (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3164 | 21 CFR 820.184(d) | Acceptance records |
| 3227 | 21 CFR 820.70(g)(1) | Activity documentation |
| 3288 | 21 CFR 820.90(b)(1) | Documentation of disposition, justification, signature |
| 3313 | 21 CFR 820.120(d) | Records, DHR {see also 820.184(e)} |
| 3333 | 21 CFR 820.184(f) | Device identification, control numbers |
| 3397 | 21 CFR 820.80(d)(2) | Review of data and documentation |
| 3417 | 21 CFR 820.70(a)(2) | Production monitoring and control |
| 3680 | 21 CFR 820.70(a) | Process control procedures, Lack of or inadequate procedures |
| 3696 | 21 CFR 820.100(b) | Documentation |
| 3837 | 21 CFR 820.25(b) | Training records |