Overview
- 13 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-03-21.
At a glance
Inspections
13
Form 483s
4
EIRs
3
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 19 Mar 2024 – 21 Mar 2024 | Human Drugs | Clean | |
| 20 Mar 2023 – 28 Mar 2023 | Human Drugs | 483 | On file |
| 12 Oct 2022 – 13 Oct 2022 | Human Drugs | Clean | |
| 5 Feb 2019 – 8 Feb 2019 | Human Drugs | Clean | |
| 13 Apr 2018 – 19 Apr 2018 | Human Drugs | Clean | |
| 9 Mar 2017 – 17 Mar 2017 | Human Drugs | 483 | View 483 → |
| 29 Mar 2016 – 1 Apr 2016 | Medical Devices & Rad Health | Clean | |
| 11 Jun 2015 – 19 Jun 2015 | Human Drugs | 483 | View 483 → |
| 8 Jul 2013 – 16 Jul 2013 | Human Drugs | Clean | |
| 25 Mar 2011 | Not recorded | Clean | |
| 3 Dec 2009 | Not recorded | Clean | |
| 3 Jul 2009 | Not recorded | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
Investigators
FDA investigators tied to this site in the record.
MRA M BarbosaR1 insp.
Wayne E Seifert1 insp.
MRA B KambereM1 insp.
MRA DavisM1 insp.
Steven P Donald1 insp.
Massoud Motamed1 insp.
Sarah M Forney1 insp.
Katherine E Jacobitz1 insp.
Xiaokuang Lai1 insp.
Robert C Steyert1 insp.
Stefanie L Heckman1 insp.
Stephen D Brown1 insp.
Aaron L Dunbar1 insp.
Thomas J Arista1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 123.9(f) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(10)(iv) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Fresenius Kabi Austria's 4 Form 483s
Source PDFs, verbatim observations, and recurring CFR citations, so your team knows what this site gets cited for.
- The site's full inspection history, with every Form 483 and its outcome
- Warning letters and recalls tied to the company behind it
- Whether recurring CFR citations get closed out or repeat