# FDA 483 - Fresenius Kabi USA, LLC - August 12, 2019

Source: https://www.globalkeysolutions.net/records/483/fresenius-kabi-usa-llc/90344142-2ce1-4a03-96d2-df8dfafa023e

> FDA 483 for Fresenius Kabi USA, LLC on August 12, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Fresenius Kabi USA, LLC
- Inspection Date: 2019-08-12
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: Fresenius Kabi USA, LLC, a sterile drug manufacturer in Grand Island, NY, received a Form 483 with two observations. The firm failed to establish adequate control procedures for manufacturing processes, specifically regarding the evaluation of decontamination effects on drug product compatibility. Additionally, the quality control unit did not perform timely reviews of analytical data, leading to issues with impurity results for Vancomycin products.

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## Related Officers

- [Johana P Brea](https://www.globalkeysolutions.net/people/johana-p-brea/2a05d734-749c-44c1-8dd1-92e0d46ea598)
- [Investigator](https://www.globalkeysolutions.net/people/marcellinus-d-dordunoo/a0e35c24-0cf5-4b11-95ba-1693fa3ecb3a)
- [Consumer Safety Officer](https://www.globalkeysolutions.net/people/rajiv-r-srivastava/05b42bfd-0cf4-42ce-89e1-b81bf36eaa17)

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

Office: https://www.globalkeysolutions.net/offices/new-jersey-district-office/6ff5e2e9-5cff-44c7-af24-5a55329a8248