FDA Inspection 1298508 — HG Medical Gmbh
The FDA completed an inspection of HG Medical Gmbh on January 9, 2026 in Raisting. 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
- January 9, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Raisting (Germany)
Citations
| ID | CFR | Description |
|---|---|---|
| 3225 | 21 CFR 820.70(g)(3) | Adjustment |
| 539 | 21 CFR 820.70(b) | Production and Process Change Procedures, lack of or Inad. |