Company
GermanyKarl Storz GMBH & Co KG (KSVEM), Garching-Hochbruck, Germany – FDA Inspections
Inspection records and compliance data for Karl Storz GMBH & Co KG (KSVEM) in Garching-Hochbruck. 4 FDA inspections on record (1 OAI), 2 Form 483s, last inspected January 29, 2018.
Company Profile
This profile covers Karl Storz GMBH & Co KG (KSVEM) based in Garching-Hochbruck, Germany.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 1
- VAI
- 1
- NAI
- 0
- Unclassified
- 2
- Form 483s
- 2
- Warning letters
- 0
First inspected October 29, 2009. Last inspected January 29, 2018.
Most cited issue areas
- Calibration, Inspection, etc. Procedures Lack of or Inadequ1 inspection
- Documentation1 inspection
- Lack of or inadequate process validation1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| January 29, 2018 | Not classified | Medical Devices & Rad Health | 1079273 |
| March 14, 2017 | Not classified | Medical Devices & Rad Health | 1017728 |
| November 28, 2012 | VAI | Medical Devices & Rad Health · Compliance: Devices | 809270 |
| October 29, 2009 | OAI | Medical Devices & Rad Health · Compliance: Devices | 628046 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Karl Storz GMBH & Co KG (KSVEM)
FEI Number
3006453991
Address
Carl-Von-Linde Str. 15, Garching-Hochbruck, Germany
Country
Germany
ID: 9dee5d3e-560c-43d2-bc46-ab2dc0fa79fe