# FDA 483 - Fresenius Kabi USA, LLC - March 06, 2015

Source: https://www.keypedia.com/records/483/fresenius-kabi-usa-llc/5a97e654-80ca-4e64-89c7-e6f46bad9237

> FDA 483 for Fresenius Kabi USA, LLC on March 06, 2015. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Fresenius Kabi USA, LLC
- Inspection Date: 2015-03-06
- 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 deficiencies in drug product manufacturing processes. Observations included a lack of established acceptable yield for bulk material and incomplete documentation of product loss, hindering process assessment. Additionally, the firm's environmental monitoring system in aseptic processing areas was found to be deficient, with re-testing performed without proper invalidation of original out-of-spec results.

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## Related Officers

- [James D. Bridges](https://www.keypedia.com/people/james-d-bridges/8ce30e52-4b32-4d12-84a2-b2a9ce8f6f53)

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