FDA Inspection 1121364 — Karl Storz SE & Co. KG
The FDA completed an inspection of Karl Storz SE & Co. KG on Mar 12, 2020 in Tuttlingen. 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). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Mar 12, 2020
- Fiscal Year
- 2020
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Tuttlingen (Germany)
Citations
| ID | CFR | Description |
|---|---|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 3409 | 21 CFR 820.200(d) | Service reports |
| 541 | 21 CFR 820.70(c) | Environmental control Lack of or inadequate procedures |