# FDA 483 - CSL Plasma Inc. - November 22, 2019

Source: https://www.keypedia.com/records/483/csl-plasma-inc/4ebc59f3-6ba1-4433-a26f-4c9cf1fe69db

> FDA 483 for CSL Plasma Inc. on November 22, 2019. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: CSL Plasma Inc.
- Inspection Date: 2019-11-22
- Product Type: biologics
- Office Name: Cincinnati District Office
- Summary: CSL Plasma Inc. in Toledo, OH, was cited for two observations during an FDA inspection. The firm failed to provide illiterate donors with required audio educational materials on subsequent visits, impacting numerous plasma donations. Additionally, the company failed to submit a biological product deviation report concerning this issue, despite processing units from the affected donors.

## Related Officers

- [Compliance Officer at FDA](https://www.keypedia.com/people/lauren-m-lilly/41582ad0-67b1-4c60-99e2-c1e3c63811c2)

Company: https://www.keypedia.com/companies/csl-plasma-inc/c1d10fdd-5419-467c-85c2-1a39a11917d9

Office: https://www.keypedia.com/offices/cincinnati-district-office/b67a0c35-82e3-4176-9039-988378f65c22