FDA Inspection 628046 — Karl Storz GMBH & Co KG (KSVEM)
The FDA completed an inspection of Karl Storz GMBH & Co KG (KSVEM) on Oct 29, 2009 in Garching-Hochbruck. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 4 citations were issued during this inspection. Product area: Devices.
Inspection details
- Classification
- Official Action Indicated (OAI)
- End Date
- Oct 29, 2009
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Garching-Hochbruck (Germany)
Citations
| ID | CFR | Description |
|---|---|---|
| 3233 | 21 CFR 820.72(a) | Calibration, Inspection, etc. Procedures Lack of or Inadequ |
| 3282 | 21 CFR 820.90(a) | Nonconforming product, Lack of or inadequate procedures |
| 3696 | 21 CFR 820.100(b) | Documentation |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |