FDA Inspection
Karl Storz GMBH & Co KG (KSVEM)Karl Storz GMBH & Co KG (KSVEM) – FDA Inspection, Oct 29, 2009
Record Details
This FDA Inspection record concerns Karl Storz GMBH & Co KG (KSVEM), with an inspection on October 29, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- October 29, 2009
- Product Type
- Devices
View Company Profile
ID · 55bd5353-36ab-4a75-97d7-6c8373ba3cbf
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 628046
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Karl Storz GMBH & Co KG (KSVEM)
3| Date | Classification | Office | Project area |
|---|---|---|---|
| January 29, 2018 | Not classified | Office of Inspections and Investigations | |
| March 14, 2017 | Not classified | Office of Inspections and Investigations | |
| November 28, 2012 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Karl Storz GMBH & Co KG (KSVEM)
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.