FDA Inspection 834679 — Vortran Medical Technology 1, Inc
The FDA completed an inspection of Vortran Medical Technology 1, Inc on May 29, 2013 in Sacramento, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 29, 2013
- Fiscal Year
- 2013
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Sacramento, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3103 | 21 CFR 820.30(i) | Design changes - Lack of or Inadequate Procedures |
| 635 | 21 CFR 803.17(b)(1) | Info evaluated to determine if event was reportable |