FDA Inspection 1270229 — August Reuchlen GmbH
The FDA completed an inspection of August Reuchlen GmbH on May 2, 2025 in Tuttlingen. 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 2, 2025
- Fiscal Year
- 2025
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Tuttlingen (Germany)
Citations
| ID | CFR | Description |
|---|---|---|
| 3427 | 21 CFR 820.50(a)(2) | Supplier oversight |
| 3696 | 21 CFR 820.100(b) | Documentation |