# CSL Behring L.L.C. – FDA 483, Jun 25, 2026

Source: https://www.keypedia.com/records/483/csl-behring-llc/6e9e1450-975c-433e-a5c1-211aec8a8470

> FDA 483 for CSL Behring L.L.C. on June 25, 2026. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: CSL Behring L.L.C.
- Inspection Date: 2026-06-25
- Product Type: biologics
- Office Name: Chicago District Office
- Summary: CSL Behring L.L.C. in Bradley, IL, a biologic drug manufacturer, was cited for failing to thoroughly investigate unexplained discrepancies regarding drug substance/intermediate batches. Specifically, the firm did not adequately address Penicillium contamination found in intermediate batches used to produce drug products like Privigen and Zemaira, raising concerns about patient safety due to potential toxins. The investigation was found deficient in its sampling scheme and scope, failing to fully assess the extent of contamination.

## Related Documents

- [483 - 2023-03-02](https://www.keypedia.com/records/483/csl-behring-llc/9ed98bb2-4ef5-444e-9d2c-229c90b4bf01) — date: March 2, 2023
- [483 - 2021-09-24](https://www.keypedia.com/records/483/csl-behring-llc/37004fc7-b0a2-4fcc-b296-786afaf88e7e) — date: September 24, 2021
- [483 - 2019-05-13](https://www.keypedia.com/records/483/csl-behring-llc/7b4594cd-1c63-42a9-b9c3-0335c26fe365) — date: May 13, 2019
- [EIR - 2018-10-18](https://www.keypedia.com/records/eir/csl-behring-llc/4255a423-d5a1-4e05-b2c3-ccf2e8ccac3e) — date: October 18, 2018

## Related Officers

- [David A. Moore](https://www.keypedia.com/people/david-a-moore/361e4fe8-caf0-4320-963a-3838616850e2)
- [Gene D. Arcy](https://www.keypedia.com/people/gene-d-arcy/a2def947-65fb-4056-84e2-1f89cf944cf0)

Company: https://www.keypedia.com/companies/csl-behring-llc/bb057a50-8ebe-4207-b535-b5ecc4b342d9

Office: https://www.keypedia.com/offices/chicago-district-office/a510300b-0eaf-4a33-90b5-231d95977669