# FDA 483 - Fresenius Kabi USA, LLC - March 30, 2017

Source: https://www.keypedia.com/records/483/fresenius-kabi-usa-llc/463f9a6a-44e5-45a6-8b51-d075f7bf4476

> FDA 483 for Fresenius Kabi USA, LLC on March 30, 2017. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Fresenius Kabi USA, LLC
- Inspection Date: 2017-03-30
- 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 significant deficiencies in their manufacturing processes for sterile drug products. The firm failed to adequately prevent microbiological contamination, evidenced by a trend of out-of-specification bioburden results and an inadequate stopper sterilization process. Additionally, the environmental monitoring system for aseptic processing and sterilization filling lines was found to be deficient, with water observed on the floor in an ISO5 area.

## Related Documents

- [483 - 2023-08-30](https://www.keypedia.com/records/483/fresenius-kabi-usa-llc/91efc984-74c0-4435-9a5c-15f4efbc26a7)
- [483 - 2016-02-04](https://www.keypedia.com/records/483/fresenius-kabi-usa-llc/ac69efb9-d106-4581-b88d-dc3e158ca870)
- [483 - 2014-10-24](https://www.keypedia.com/records/483/fresenius-kabi-usa-llc/748ccfb6-38af-4b50-af00-f7af728729ca)
- [483 - 2019-08-12](https://www.keypedia.com/records/483/fresenius-kabi-usa-llc/90344142-2ce1-4a03-96d2-df8dfafa023e)
- [483 - 2018-06-29](https://www.keypedia.com/records/483/fresenius-kabi-usa-llc/073d0262-f2d1-4776-9be6-655e8bbf723d)

## Related Officers

- [issuing_officer](https://www.keypedia.com/people/erika-englund/13d235ca-da4b-40e3-add0-c62372c8c25e)
- [Mandy Chan](https://www.keypedia.com/people/mandy-chan/437eb591-92d9-49ac-943c-33c7584c0b89)
- [Director, Team Biologics Staff](https://www.keypedia.com/people/helen-b-ricalde/455f022e-4d32-453e-acc7-e84a53ce730c)

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