# FDA 483 - CSL Behring L.L.C. - September 24, 2021

Source: https://www.keypedia.com/records/483/csl-behring-llc/37004fc7-b0a2-4fcc-b296-786afaf88e7e

> FDA 483 for CSL Behring L.L.C. on September 24, 2021. 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: 2021-09-24
- Product Type: biologics
- Office Name: Chicago District Office
- Summary: The FDA inspection of CSL Behring LLC in Bradley, IL, revealed significant deficiencies in aseptic processing areas, including widespread mold contamination and HEPA filter failures. The firm also failed to effectively implement corrective actions for equipment maintenance, ensure product manufacturing adhered to approved licenses, and maintain compliance with established procedures for plasma lookbacks and operator conduct. These issues collectively indicate a lack of adequate control over environmental conditions, equipment integrity, and procedural adherence, posing potential risks to product quality and safety.

## Related Documents

- [EIR - 2018-10-18](https://www.keypedia.com/records/eir/csl-behring-llc/4255a423-d5a1-4e05-b2c3-ccf2e8ccac3e)
- [483 - 2019-05-13](https://www.keypedia.com/records/483/csl-behring-llc/7b4594cd-1c63-42a9-b9c3-0335c26fe365)
- [483 - 2023-03-02](https://www.keypedia.com/records/483/csl-behring-llc/9ed98bb2-4ef5-444e-9d2c-229c90b4bf01)

## Related Officers

- [Program Expert for Advanced Manufacturing ](https://www.keypedia.com/people/prabhu-p-raju/2c0aaede-fe16-4431-bc21-614d7f18cb32)
- [Strategic Expert at NovoNordisk; Retired from FDA](https://www.keypedia.com/people/debra-m-emerson/58bd7fac-28eb-4369-b149-13a24cc00cf7)
- [CO CDER OMQ](https://www.keypedia.com/people/claire-minden/f48982ad-244e-41a8-932a-5d7a2392f0e3)

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