FDA Inspection 979975 — Symmetry Medical USA Inc.
The FDA completed an inspection of Symmetry Medical USA Inc. on Jun 15, 2016 in Warsaw, IN. 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). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jun 15, 2016
- Fiscal Year
- 2016
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Warsaw, IN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3127 | 21 CFR 820.80(e) | Documentation |
| 3128 | 21 CFR 820.90(a) | Nonconforming product control |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |