Company
NetherlandsCablon Medical B.V., Leusden, Netherlands – FDA Inspections
Inspection records and compliance data for Cablon Medical B.V. in Leusden. 2 FDA inspections on record, 1 Form 483, last inspected February 15, 2023.
Company Profile
This profile covers Cablon Medical B.V. based in Leusden, Netherlands.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 2
- NAI
- 0
- Form 483s
- 1
- Warning letters
- 0
First inspected July 21, 2011. Last inspected February 15, 2023.
Most cited issue areas
- Design output - documentation1 inspection
- DMR - not or inadequately maintained1 inspection
- Documentation of software validation1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| February 15, 2023 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1197434 |
| July 21, 2011 | VAI | Medical Devices & Rad Health · Compliance: Devices | 737692 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Cablon Medical B.V.
FEI Number
3003062786
Address
Klepelhoek 11, Leusden, Netherlands
Country
Netherlands
ID: 193fc8aa-9494-46bc-ba09-579d430b48d2