FDA Inspection 1279033 — Gb Implantat Technologie GMBH
The FDA completed an inspection of Gb Implantat Technologie GMBH on Aug 21, 2025 in Bochum. 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). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Aug 21, 2025
- Fiscal Year
- 2025
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Bochum (Germany)
Citations
| ID | CFR | Description |
|---|---|---|
| 14721 | 21 CFR 820.70(g)(2) | Periodic equipment inspections |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3235 | 21 CFR 820.72(a) | Equipment control activity documentation |
| 3282 | 21 CFR 820.90(a) | Nonconforming product, Lack of or inadequate procedures |