FDA Inspection 807643 — Karl Storz SE & Co. KG
The FDA completed an inspection of Karl Storz SE & Co. KG on Oct 18, 2012 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). 5 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Oct 18, 2012
- Fiscal Year
- 2013
- Product Type
- Devices
- Project Area
- Project Evaluation: Devices
- Location
- Tuttlingen (Germany)
Additional Details
Postmarket Audit Inspections
Citations
| ID | CFR | Description |
|---|---|---|
| 14712 | 21 CFR 820.184 | DHR - not or inadequately maintained |
| 3108 | 21 CFR 820.70(e) | Contamination control, Lack of or inadequate procedures |
| 3132 | 21 CFR 820.120 | Lack of or inadequate procedures for labeling |
| 3310 | 21 CFR 820.120(b) | DHR documentation of label release {see also 820.184} |
| 539 | 21 CFR 820.70(b) | Production and Process Change Procedures, lack of or Inad. |