FDA Inspection 1108917 — Somatex Medical Technologies GMBH
The FDA completed an inspection of Somatex Medical Technologies GMBH on November 6, 2019 in Berlin. 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
- November 6, 2019
- Fiscal Year
- 2020
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Berlin (Germany)
Citations
| ID | CFR | Description |
|---|---|---|
| 2327 | 21 CFR 820.22 | Quality audits - Lack of or inadequate procedures |
| 3118 | 21 CFR 820.75(a) | Documentation |
| 731 | 21 CFR 803.50(a)(1) | Report of Death or Serious Injury |