FDA Inspection 1198202 — Pausch Medical GmbH
The FDA completed an inspection of Pausch Medical GmbH on February 24, 2023 in Erlangen. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 1 citation was issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 24, 2023
- Fiscal Year
- 2023
- Product Type
- Devices
- Project Area
- Radiation Control and Health Safety Act
- Location
- Erlangen (Germany)
Citations
| ID | CFR | Description |
|---|---|---|
| 5700 | 21 CFR 1002.10 | Failure to submit, distinct marking |