# FDA 483 - Fresenius Kabi USA LLC - August 24, 2023

Source: https://www.keypedia.com/records/483/fresenius-kabi-usa-llc/183d3035-6c45-45d2-9875-3c4a6db4457e

> FDA 483 for Fresenius Kabi USA LLC on August 24, 2023. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Fresenius Kabi USA LLC
- Inspection Date: 2023-08-24
- Product Type: drugs
- Office Name: Chicago District Office
- Summary: Fresenius Kabi USA LLC in Melrose Park, IL, a sterile drug manufacturer, received a Form 483 citing significant deficiencies in their quality control unit's procedures. Observations included improper bioburden plate enumeration for Water for Injection samples, incorrect personnel monitoring practices in the aseptic core, and a failure to contemporaneously record data in QC chemistry logbooks. These issues indicate a lack of adherence to established procedures and data integrity principles.

## Related Documents

- [483 - 2013-12-11](https://www.keypedia.com/records/483/fresenius-kabi-usa-llc/74b1c598-2a46-48fa-900b-2a48f0906013)
- [483 - 2015-09-01](https://www.keypedia.com/records/483/fresenius-kabi-usa-llc/bf293339-7005-45af-931f-376032c0316d)
- [483 - 2020-05-18](https://www.keypedia.com/records/483/fresenius-kabi-usa-llc/c5c70f4e-1342-4dae-8ea8-fdfc56c82c6f)
- [483 - 2020-05-18](https://www.keypedia.com/records/483/fresenius-kabi-usa-llc/d336177f-cc20-4bc6-a876-9138e3d07f5a)
- [483 - 2022-06-30](https://www.keypedia.com/records/483/fresenius-kabi-usa-llc/f85aed16-5fb4-4bea-9af4-d3c50dfa74b0)

## Related Officers

- [Nicholas J. Presto](https://www.keypedia.com/people/nicholas-j-presto/2ecdd573-6662-4d07-b93c-ddb9c603bcfa)
- [Andrew J. Barrowcliff](https://www.keypedia.com/people/andrew-j-barrowcliff/5dd49407-9028-4c84-9e86-3f0b6239538e)
- [investigator](https://www.keypedia.com/people/chad-w-rice/b00f381a-744d-4e5e-90bf-07f60f494afc)
- [Investigator](https://www.keypedia.com/people/alan-m-barker/cf7b4907-0505-418e-860c-815acd534afe)

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

Office: https://www.keypedia.com/offices/chicago-district-office/a510300b-0eaf-4a33-90b5-231d95977669