FDA Inspection 590341 — Symmetry Surgical, Inc.
The FDA completed an inspection of Symmetry Surgical, Inc. on Jun 10, 2009 in Antioch, TN. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 7 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Jun 10, 2009
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Antioch, TN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2302 | 21 CFR 820.20(e) | Quality System Procedures |
| 2327 | 21 CFR 820.22 | Quality audits - Lack of or inadequate procedures |
| 2351 | 21 CFR 820.25(b) | Training |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3306 | 21 CFR 820.100(a)(7) | Management review |
| 4189 | 21 CFR 820.198(a) | General |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |