# FDA 483 - Fresenius Kabi USA LLC - February 17, 2026

Source: https://www.keypedia.com/records/483/fresenius-kabi-usa-llc/99c065c1-e60a-4b69-8464-42ed80d0b1a4

> FDA 483 for Fresenius Kabi USA LLC on February 17, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Fresenius Kabi USA LLC
- Inspection Date: 2026-02-17
- Product Type: drugs
- Office Name: FDA District Office — Chicago, Illinois
- Summary: Fresenius Kabi USA LLC, a sterile drug manufacturer in Melrose Park, IL, received a Form 483 citing significant deficiencies across multiple areas. The observations highlight inadequate investigations into critical product defects like foreign particulates and sterility failures, insufficient validation of visual inspection methods, and widespread failures in aseptic processing controls. Repeated issues with environmental monitoring, aseptic technique, and equipment maintenance indicate a systemic lack of control over sterile drug manufacturing processes.

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## Related Officers

- [Joohi Castelvetere](https://www.keypedia.com/people/joohi-castelvetere/2340bef8-5105-4f40-9713-120196b70d82)
- [Investigator?](https://www.keypedia.com/people/robert-j-ham/9146e819-4fce-420c-a722-cbe14e3c6afb)
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- [Angela C. Welker](https://www.keypedia.com/people/angela-c-welker/b732b19f-c8e8-43b0-bc81-8dcde8a53c84)

Company: https://www.keypedia.com/companies/fresenius-kabi-usa-llc/f694c817-29ea-47cf-b819-8cf11fbfc4da

Office: https://www.keypedia.com/offices/fda-district-office-chicago-illinois/62c2811c-10c5-4d74-99d0-eb5047ef3b65