# FDA 483 - CSL Behring L.L.C. - May 13, 2019

Source: https://www.globalkeysolutions.net/records/483/csl-behring-llc/7b4594cd-1c63-42a9-b9c3-0335c26fe365

> FDA 483 for CSL Behring L.L.C. on May 13, 2019. 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: 2019-05-13
- Product Type: biologics
- Office Name: Chicago District Office
- Summary: CSL Behring LLC in Bradley, IL, was cited for significant deficiencies in its aseptic processing and manufacturing controls. The inspection revealed inadequate validation of aseptic processes, including multiple media fill failures, and a lack of established procedures for preventing microbiological contamination. Further issues included insufficient environmental monitoring, unestablished time limits for production phases, poorly maintained equipment, and general facility maintenance problems.

## Related Documents

- [EIR - 2018-10-18](https://www.globalkeysolutions.net/records/eir/csl-behring-llc/4255a423-d5a1-4e05-b2c3-ccf2e8ccac3e)
- [483 - 2021-09-24](https://www.globalkeysolutions.net/records/483/csl-behring-llc/37004fc7-b0a2-4fcc-b296-786afaf88e7e)
- [483 - 2023-03-02](https://www.globalkeysolutions.net/records/483/csl-behring-llc/9ed98bb2-4ef5-444e-9d2c-229c90b4bf01)

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/richard-t-riggie/d07a4551-08b4-44f7-b7d2-02ae3c5dc1e2)
- [Compliance Officer](https://www.globalkeysolutions.net/people/randall-l-morris/91b75634-8ee0-43bb-a4b4-a37780fa2b45)
- [CSO](https://www.globalkeysolutions.net/people/mihaly-s-ligmond/2904ef70-a757-49c7-9ac4-a2c07ee36001)

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

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