# FDA 483 - Fresenius Kabi USA, LLC - June 29, 2018

Source: https://www.keypedia.com/records/483/fresenius-kabi-usa-llc/073d0262-f2d1-4776-9be6-655e8bbf723d

> FDA 483 for Fresenius Kabi USA, LLC on June 29, 2018. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Fresenius Kabi USA, LLC
- Inspection Date: 2018-06-29
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: An FDA inspection of Fresenius Kabi USA, LLC in Grand Island, NY, revealed six observations concerning significant deficiencies in manufacturing controls and quality systems. The firm failed to evaluate material compatibility, maintain complete batch records, and adhere to written procedures for cleaning validation. Additionally, issues were noted with timely Field Alert Report submissions and the quality control unit's written procedures and oversight of contract laboratories.

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## Related Officers

- [William Leonard](https://www.keypedia.com/people/william-leonard/1f11ece4-597c-4d3e-aac4-46f8ea404ec3)
- [Consumer Safety Officer Drug Specialist](https://www.keypedia.com/people/sony-mathews/4d42379f-1245-494c-8c19-6cefa4e560a5)

Company: https://www.keypedia.com/companies/fresenius-kabi-usa-llc/f0c47fa1-3b76-4e6c-82dd-d703086bdfdc

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