# FDA 483 - Fresenius Kabi Austria GMBH - March 28, 2023

Source: https://www.keypedia.com/records/483/fresenius-kabi-austria-gmbh/c03175d3-f8d3-4a0c-b331-47b2c8e66729

> FDA 483 for Fresenius Kabi Austria GMBH on March 28, 2023. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Fresenius Kabi Austria GMBH
- Inspection Date: 2023-03-28
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of Fresenius Kabi Austria GmbH - (FK-Graz) in Graz, Austria, a drug product manufacturer, revealed significant deficiencies across multiple areas. The firm failed to establish or follow adequate process controls, leading to potential contamination risks, issues with aseptic processing, and uncalibrated equipment. Additionally, a utility system was found to be improperly located and maintained, and several manufacturing and validation procedures were deemed deficient.

## Related Officers

- [Senior Regulatory Specialist](https://www.keypedia.com/people/wayne-e-seifert/e92e1f10-c61e-4b08-9156-25907e5e2942)

Company: https://www.keypedia.com/companies/fresenius-kabi-austria-gmbh/c9bae950-9cd9-46e8-82bd-c77512d8af99

Office: https://www.keypedia.com/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd