FDA Inspection 846112 — Karl Storz Endovision, Inc.
The FDA completed an inspection of Karl Storz Endovision, Inc. on August 26, 2013 in Charlton, MA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 26, 2013
- Fiscal Year
- 2013
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Charlton, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3159 | 21 CFR 820.184 | DHR content |
| 3226 | 21 CFR 820.70(g)(1) | Maintenance schedule, Lack of or inadequate schedule |
| 3680 | 21 CFR 820.70(a) | Process control procedures, Lack of or inadequate procedures |