# FDA 483 - Fresenius Kabi USA LLC - May 18, 2020

Source: https://www.keypedia.com/records/483/fresenius-kabi-usa-llc/c5c70f4e-1342-4dae-8ea8-fdfc56c82c6f

> FDA 483 for Fresenius Kabi USA LLC on May 18, 2020. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Fresenius Kabi USA LLC
- Inspection Date: 2020-05-18
- Product Type: drugs
- Office Name: Chicago District Office
- Summary: An FDA inspection of Fresenius Kabi USA LLC in Melrose Park, IL, revealed significant deficiencies in quality control, equipment cleaning, aseptic processing, batch record documentation, and investigation procedures. The firm failed to adequately address particulate matter in Ketorolac, cross-contamination with Lidocaine in Dexmedetomidine, and lacked proper controls for sterile drug product manufacturing and hold times. These issues indicate a lack of adherence to current good manufacturing practices.

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## Related Officers

- [Brian D. Nicholson](https://www.keypedia.com/people/brian-d-nicholson/83ea13dd-6753-468a-a0ca-19e3ef4158dd)
- [Michele L. Glendenning](https://www.keypedia.com/people/michele-l-glendenning/a3c23a43-634c-4140-807b-c17fbc03bb00)

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