Company
AustriaFresenius Kabi Austria GMBH, Graz, Austria – FDA Inspections
Inspection records and compliance data for Fresenius Kabi Austria GMBH in Graz. 13 FDA inspections on record, 2 Form 483s, last inspected March 21, 2024.
Company Profile
This profile covers Fresenius Kabi Austria GMBH based in Graz, Austria.
FDA Inspection History
- FDA inspections
- 13
- OAI
- 0
- VAI
- 7
- NAI
- 4
- Unclassified
- 2
- Form 483s
- 2
- Warning letters
- 0
First inspected July 3, 2009. Last inspected March 21, 2024.
Most cited issue areas
- Cleaning / Sanitizing / Maintenance1 inspection
- Computerized records1 inspection
- Environmental Monitoring System1 inspection
FDA inspections (13)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| March 21, 2024 | VAI | Human Drugs · Drug Quality Assurance | 1251340 |
| March 28, 2023 | Not classified | Human Drugs | 1205334 |
| October 13, 2022 | VAI | Human Drugs · Drug Quality Assurance | 1207391 |
| January 30, 2020 | VAI | Human Drugs · Drug Quality Assurance | 1162216 |
| April 19, 2018 | Not classified | Human Drugs | 1052462 |
| February 8, 2018 | VAI | Human Drugs · Drug Quality Assurance | 1094504 |
| March 17, 2017 | VAI | Human Drugs · Drug Quality Assurance | 1005862 |
| April 1, 2016 | NAI | Medical Devices & Rad Health · Compliance: Devices | 969912 |
| June 19, 2015 | VAI | Human Drugs · Drug Quality Assurance | 947009 |
| July 16, 2013 | NAI | Human Drugs · Drug Quality Assurance | 845938 |
| March 25, 2011 | NAI | Human Drugs · Drug Quality Assurance | 721204 |
| December 3, 2009 | NAI | Medical Devices & Rad Health · Compliance: Devices | 638027 |
| July 3, 2009 | VAI | Human Drugs · Drug Quality Assurance | 611006 |
FDA documents
Form 483s (1)
People (1)
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Company Information
Name
Fresenius Kabi Austria GMBH
FEI Number
3003708554
Address
Hafnerstrase 36, Graz, Austria
Country
Austria
ID: c9bae950-9cd9-46e8-82bd-c77512d8af99