# FDA 483 - CSL Plasma Inc. - Unknown Date

Source: https://www.keypedia.com/records/483/csl-plasma-inc/354d8bb2-b9da-41b1-a629-882c63b86154

> FDA 483 for CSL Plasma Inc. on Unknown Date. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: CSL Plasma Inc.
- Product Type: biologics
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: CSL Plasma, Inc. in Baltimore, Maryland, was issued a Form FDA 483 following an inspection from December 14-16, 2016, citing two observations. The firm failed to consistently notify deferred donors of transfusion-transmitted infection test results and did not adequately examine donor phlebotomy sites for signs of infection or drug abuse. These findings indicate significant deficiencies in donor management and screening procedures.

## Related Officers

- [Jody R. Crandall, CSO, CBER](https://www.keypedia.com/people/jody-r-crandall-cso-cber/00313193-023c-4620-a7ef-cfb174820d0b)
- [Brandon L. Mariner, Investigator, ORA](https://www.keypedia.com/people/brandon-l-mariner-investigator-ora/1058b9d6-ac94-4b41-98f3-42821d3d2e9d)
- [Patricia E. Weddington](https://www.keypedia.com/people/patricia-e-weddington/181e81aa-12f9-4e7b-a662-f1926237c25c)

Company: https://www.keypedia.com/companies/csl-plasma-inc/94a93e1f-ffe1-47a0-b454-e895fc5db702

Office: https://www.keypedia.com/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd