# FDA 483 - Fresenius Kabi USA LLC - December 11, 2013

Source: https://www.globalkeysolutions.net/records/483/fresenius-kabi-usa-llc/74b1c598-2a46-48fa-900b-2a48f0906013

> FDA 483 for Fresenius Kabi USA LLC on December 11, 2013. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Fresenius Kabi USA LLC
- Inspection Date: 2013-12-11
- Product Type: drugs
- Office Name: Chicago District Office
- Summary: An FDA inspection of Fresenius Kabi USA LLC in Melrose Park, IL, a sterile injectable drug product manufacturer, revealed significant deficiencies. These included failures in following quality control unit procedures, inadequate equipment design for cleaning, and a lack of established procedures to prevent microbiological contamination. These issues led to product recalls and potential risks to product sterility.

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- [Investigator](https://www.globalkeysolutions.net/people/russell-k-riley/4813d9c2-52a3-4eba-8606-d4be5e03fd04)
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Company: https://www.globalkeysolutions.net/companies/fresenius-kabi-usa-llc/f694c817-29ea-47cf-b819-8cf11fbfc4da

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