FDA Inspection 649307 — VOT LLC
The FDA completed an inspection of VOT LLC on Feb 26, 2010 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). 10 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Feb 26, 2010
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Warsaw, IN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2350 | 21 CFR 820.25(b) | Training - Lack of or inadequate procedures |
| 2470 | 21 CFR 820.30(c) | Design input procedures - appropriateness |
| 2648 | 21 CFR 820.30(f) | Design verification procedures |
| 3103 | 21 CFR 820.30(i) | Design changes - Lack of or Inadequate Procedures |
| 3170 | 21 CFR 820.198(b) | Review and evaluation for investigation |
| 3201 | 21 CFR 820.40(a) | Not approved or obsolete document retrieval |
| 3415 | 21 CFR 820.22 | Quality Audit/Reaudit - conducted |
| 3425 | 21 CFR 820.50(a)(1) | Evaluation and Selection, Suppliers, Contractors, etc. |
| 447 | 21 CFR 820.40 | Lack of procedures, or not maintained |
| 783 | 21 CFR 803.52(f)(6) | Evaluation Codes |