Company
GermanyBAK KOHLER Medical KG, Neuhausen Ob Eck Schwandor, Germany – FDA Inspections
Inspection records and compliance data for BAK KOHLER Medical KG in Neuhausen Ob Eck Schwandor. 2 FDA inspections on record, 1 Form 483, last inspected September 27, 2018.
Company Profile
This profile covers BAK KOHLER Medical KG based in Neuhausen Ob Eck Schwandor, Germany.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 1
- NAI
- 0
- Unclassified
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected January 19, 2012. Last inspected September 27, 2018.
Most cited issue areas
- Lack of or inadequate procedures2 inspections
- Design verification - output does not meet input requirement1 inspection
- Documentation1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| September 27, 2018 | Not classified | Medical Devices & Rad Health · Compliance: Devices | 1066877 |
| January 19, 2012 | VAI | Medical Devices & Rad Health · Compliance: Devices | 768246 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
BAK KOHLER Medical KG
FEI Number
3005276402
Address
Hauptstr. 5a, Neuhausen Ob Eck Schwandor, Germany
Country
Germany
ID: b0b8684e-ecda-4a01-83bb-8a43049dad9b