# FDA 483 - CSL Plasma Inc. - July 18, 2019

Source: https://www.keypedia.com/records/483/csl-plasma-inc/08008369-2b3d-47a1-953f-082757b40ca2

> FDA 483 for CSL Plasma Inc. on July 18, 2019. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: CSL Plasma Inc.
- Inspection Date: 2019-07-18
- Product Type: biologics
- Office Name: Cincinnati District Office
- Summary: During an inspection from July 11-18, 2019, CSL Plasma Inc. in Columbus, OH, was cited for a significant failure in its medical history assessment process. A donor who openly discussed heroin use was improperly screened and allowed to proceed to donation, indicating a serious lapse in preventing the collection of potentially unsafe plasma.

## Related Officers

- [Jennifer L. Sheehan](https://www.keypedia.com/people/jennifer-l-sheehan/a49c628d-6eba-4b52-bafc-70785b9ba75e)

Company: https://www.keypedia.com/companies/csl-plasma-inc/9472157e-a1bb-4798-91bd-eecd25b4b81e

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