Company
GermanyFresenius Medical Care Deutschland Gmbh, St. Wendel, Germany – FDA Inspections
Inspection records and compliance data for Fresenius Medical Care Deutschland Gmbh in St. Wendel. 4 FDA inspections on record, 1 Form 483, last inspected June 29, 2023.
Company Profile
This profile covers Fresenius Medical Care Deutschland Gmbh based in St. Wendel, Germany.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 0
- VAI
- 1
- NAI
- 3
- Form 483s
- 1
- Warning letters
- 0
First inspected June 9, 2017. Last inspected June 29, 2023.
Most cited issue areas
- Computer control of master formula records1 inspection
- Investigations of discrepancies, failures1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| June 29, 2023 | NAI | Human Drugs · Drug Quality Assurance | 1290514 |
| May 2, 2023 | VAI | Human Drugs · Drug Quality Assurance | 1205261 |
| June 24, 2020 | NAI | Human Drugs · Drug Quality Assurance | 1204319 |
| June 9, 2017 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1017671 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Fresenius Medical Care Deutschland Gmbh
FEI Number
3002807005
Address
Frankfurter Str. 6-8, St. Wendel, Germany
Country
Germany
ID: 4196025e-cae6-429d-9bc0-ca1030e99aa2