FDA Inspection 653108 — Dornier Medtech America, Inc.
The FDA completed an inspection of Dornier Medtech America, Inc. on March 5, 2010 in Kennesaw, GA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 5, 2010
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Kennesaw, GA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3170 | 21 CFR 820.198(b) | Review and evaluation for investigation |
| 3291 | 21 CFR 820.100(b) | Procedures |
| 731 | 21 CFR 803.50(a)(1) | Report of Death or Serious Injury |