FDA Inspection 905519 — Storz Medical, AG
The FDA completed an inspection of Storz Medical, AG on Nov 21, 2014 in Tagerwilen. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI)
- End Date
- Nov 21, 2014
- Fiscal Year
- 2015
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Tagerwilen (Switzerland)
Citations
| ID | CFR | Description |
|---|---|---|
| 3160 | 21 CFR 820.184 | Lack of or inadequate DHR procedures |
| 3172 | 21 CFR 820.198(c) | Investigation of device failures |
| 3696 | 21 CFR 820.100(b) | Documentation |