FDA Inspection 809270 — Karl Storz GMBH & Co KG (KSVEM)
The FDA completed an inspection of Karl Storz GMBH & Co KG (KSVEM) on Nov 28, 2012 in Garching-Hochbruck. 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
- Nov 28, 2012
- Fiscal Year
- 2013
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Garching-Hochbruck (Germany)
Citations
| ID | CFR | Description |
|---|---|---|
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |