FDA Inspection 806237 — Vilex in Tennessee, Inc.
The FDA completed an inspection of Vilex in Tennessee, Inc. on November 1, 2012 in Mcminnville, TN. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 7 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- November 1, 2012
- Fiscal Year
- 2013
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Mcminnville, TN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2430 | 21 CFR 820.30(b) | Design plans - Lack of or inadequate |
| 2557 | 21 CFR 820.30(c) | Design input - documentation |
| 2604 | 21 CFR 820.30(e) | Design review - Lack of or inadequate procedures |
| 2650 | 21 CFR 820.30(f) | Design verification - Lack of or inadequate procedures |
| 3101 | 21 CFR 820.30(g) | Design validation- Lack of or inadequate procedures |
| 3102 | 21 CFR 820.30(h) | Design transfer - Lack of or inadequate procedures |
| 3103 | 21 CFR 820.30(i) | Design changes - Lack of or Inadequate Procedures |