Company
GermanyMedikomp Gmbh, Rastatt, Germany – FDA Inspections
Inspection records and compliance data for Medikomp Gmbh in Rastatt. 3 FDA inspections on record, 1 Form 483, last inspected May 14, 2025.
Company Profile
This profile covers Medikomp Gmbh based in Rastatt, Germany.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 2
- NAI
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected August 15, 2013. Last inspected May 14, 2025.
Most cited issue areas
- Design transfer - Lack of or inadequate procedures1 inspection
- Documentation of software validation1 inspection
- Records of complaint investigation1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| May 14, 2025 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1273889 |
| October 20, 2016 | VAI | Medical Devices & Rad Health · Compliance: Devices | 992713 |
| August 15, 2013 | VAI | Medical Devices & Rad Health · Compliance: Devices | 849117 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Medikomp Gmbh
FEI Number
3007427881
Address
Kehler Str. 31, Rastatt, Germany
Country
Germany
ID: 5f392112-51ba-4c11-9588-95d63626a58f