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

Source: https://www.keypedia.com/records/483/fresenius-kabi-usa-llc/eb0b4e2c-4c39-4ffb-a765-2f01adf7efef

> FDA 483 for Fresenius Kabi USA, LLC on June 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: 2023-06-13
- Product Type: drugs
- Office Name: Atlanta District Office
- Summary: An FDA inspection of Fresenius Kabi USA, LLC in Wilson, NC, a sterile drug manufacturer, revealed six observations concerning significant deficiencies in aseptic processing controls. Issues included inadequate procedures to prevent microbiological contamination, insufficient validation of aseptic processes, and failures in production and laboratory controls. Additionally, the firm's batch records were deficient, and there was a failure to thoroughly review unexplained discrepancies.

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## Related Officers

- [Pharmaceutical Specialist/ Investigator ](https://www.keypedia.com/people/veronica-fuentes/50ea657f-39e6-4d97-a627-86339df3fbe6)
- [Gretchen M. Laws](https://www.keypedia.com/people/gretchen-m-laws/9a3ecebd-099b-41d5-a2a7-70811a26cae1)
- [Medical Officer at FDA](https://www.keypedia.com/people/brittny-c-cargo/a3479241-5390-4ddb-b892-df0bac1c89cf)

Company: https://www.keypedia.com/companies/fresenius-kabi-usa-llc/6b662e1b-3996-48b4-a517-0d555d32a380

Office: https://www.keypedia.com/offices/atlanta-district-office/7586d99a-288e-49d1-8c3d-d88b7354b7a7