# FDA 483 - Fresenius Kabi USA, LLC - October 13, 2023

Source: https://www.keypedia.com/records/483/fresenius-kabi-usa-llc/475fcb6e-dfe5-45dd-991c-a9313ad63c64

> FDA 483 for Fresenius Kabi USA, LLC on October 13, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Fresenius Kabi USA, LLC
- Inspection Date: 2023-10-13
- 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, identified critical deficiencies in aseptic processing and quality control for sterile drug products. The firm failed to establish and follow adequate procedures to prevent microbiological contamination, including issues with environmental monitoring, airflow studies, and documentation of aseptic interventions. Additionally, the company did not thoroughly investigate unexplained discrepancies, such as recurring grease contamination during the production of Heparin Sodium Injection, USP, which was subsequently distributed.

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## Related Officers

- [Jazmine N. Brown](https://www.keypedia.com/people/jazmine-n-brown/194fc53f-942f-4e8c-a475-b7eac11be103)
- [Mindy M. Chou](https://www.keypedia.com/people/mindy-m-chou/3d0e74bf-ad6b-48b5-8b72-cbb29e9c9ce5)

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