Company
GermanyMoeller Medical GmbH, Fulda, Germany – FDA Inspections
Inspection records and compliance data for Moeller Medical GmbH in Fulda. 3 FDA inspections on record, 2 Form 483s, last inspected March 30, 2023.
Company Profile
This profile covers Moeller Medical GmbH based in Fulda, Germany.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 2
- NAI
- 0
- Unclassified
- 1
- Form 483s
- 2
- Warning letters
- 0
First inspected January 30, 2014. Last inspected March 30, 2023.
Most cited issue areas
- Design changes - validation vs. verification1 inspection
- Design input procedures - addressing conflicting requirement1 inspection
- Design validation - production units1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| March 30, 2023 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1203595 |
| March 22, 2018 | Not classified | Medical Devices & Rad Health | 1087392 |
| January 30, 2014 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 864721 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Moeller Medical GmbH
FEI Number
3002807634
Address
Wasserkuppenstr. 29-31, Fulda, Germany
Country
Germany
ID: 416c5a80-cba8-450f-8334-42a9e223c093