Fresenius Kabi Austria
Form 483 issued March 28, 2023 · Graz, Austria
- Inspection
- Mar 20 – Mar 28, 2023
- Investigator
- Wayne Seifert
- Observations
- 3
- Pages
- 3
- FEI number
- 3003708554
In short: On March 28, 2023, FDA issued a Form 483 with 3 observations to Fresenius Kabi Austria in Graz, Werndorf (FEI 3003708554) after an inspection that ran Mar 20 – Mar 28, 2023. The investigator was Wayne Seifert. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.100 (written procedures; deviations).
At a glance
2 of 3 observations on this 483 concern production.
Most cited: 21 CFR 211.100 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Failure to establish or follow process controls designed to assure that the drug products you manufacture…
- 02
A utility system is not appropriately located and maintained or designed for manufacture that could reasonably…
- 03
Procedures are deficient in support…
This inspection in context
Wayne Seifert
37 documents · 2010–2025
Cites 211.100 (written procedures; deviations) more than any other section. Most of their documents are for sites in Germany.
The firmFresenius Kabi Austria history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.100
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Fresenius Kabi Austria?
FDA listed 3 observations on this Form 483, mostly about production and facilities & equipment. The most-cited regulation is 21 CFR 211.100 (written procedures; deviations). The opening words of each observation are shown on this page.
Who inspected Fresenius Kabi Austria?
Wayne Seifert is named on this Form 483, for the inspection of Mar 20 – Mar 28, 2023. Each investigator has a profile showing what they cite most.
When was Fresenius Kabi Austria inspected by FDA?
The inspection ran Mar 20 – Mar 28, 2023, and the Form 483 is dated March 28, 2023.
How do I get the full Form 483 for Fresenius Kabi Austria?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.