FDA Inspection 1020733 — Heinz Kurz GmbH Medizintechnik
The FDA completed an inspection of Heinz Kurz GmbH Medizintechnik on Aug 3, 2017 in Duslingen. 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). 1 citation was issued during this inspection. Product area: Devices.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Aug 3, 2017
- Fiscal Year
- 2017
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Duslingen (Germany)
Citations
| ID | CFR | Description |
|---|---|---|
| 3231 | 21 CFR 820.70(i) | Documentation of software validation |