# FDA 483 - Fresenius Kabi USA, LLC - February 04, 2016

Source: https://www.globalkeysolutions.net/records/483/fresenius-kabi-usa-llc/ac69efb9-d106-4581-b88d-dc3e158ca870

> FDA 483 for Fresenius Kabi USA, LLC on February 04, 2016. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Fresenius Kabi USA, LLC
- Inspection Date: 2016-02-04
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: Fresenius Kabi USA, LLC, a sterile drug product manufacturer in Grand Island, NY, received an FDA Form 483 citing significant deficiencies. Observations included failures in the quality control unit's review of production records before batch release, inadequate investigation of unexplained discrepancies, and ineffective corrective actions for media fill contamination. Additionally, issues with employee training and the scientific justification for laboratory sampling plans were identified.

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## Related Officers

- [Charanjeet Jassal](https://www.globalkeysolutions.net/people/charanjeet-jassal/85aad819-fe9c-41dd-8280-23bcbeb8826c)
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Company: https://www.globalkeysolutions.net/companies/fresenius-kabi-usa-llc/f0c47fa1-3b76-4e6c-82dd-d703086bdfdc

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-east-i/a807f00e-d780-40b8-b233-1eb92ece8961