FDA Inspection 1065930 — Symmetry Medical, Inc.
The FDA completed an inspection of Symmetry Medical, Inc. on Sep 10, 2018 in Claypool, IN. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Sep 10, 2018
- Fiscal Year
- 2018
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Claypool, IN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3128 | 21 CFR 820.90(a) | Nonconforming product control |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3239 | 21 CFR 820.72(b) | Remedial action - documentation |
| 3263 | 21 CFR 820.250(b) | Sampling plans |