Company
GermanyKBL GmbH, Dernbach, Germany – FDA Inspections
Inspection records and compliance data for KBL GmbH in Dernbach. 3 FDA inspections on record, 1 Form 483, last inspected June 15, 2023.
Company Profile
This profile covers KBL GmbH based in Dernbach, Germany.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 0
- NAI
- 2
- Unclassified
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected September 2, 2016. Last inspected June 15, 2023.
Most cited issue areas
- ID label lacks name and address1 inspection
- Label - Warning statement1 inspection
- Management review - defined interval, sufficient frequency1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| June 15, 2023 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1210373 |
| May 17, 2019 | Not classified | Medical Devices & Rad Health · Radiation Control and Health Safety Act | 1090616 |
| September 2, 2016 | NAI | Medical Devices & Rad Health · Radiation Control and Health Safety Act | 986138 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
KBL GmbH
FEI Number
3006116732
Address
Industriepark Urbacher Wald, Ringstr. 24-26, Dernbach, Germany
Country
Germany
ID: d059bee2-d9c9-4415-b58b-28e1cfd2d3bf