# FDA 483 - CSL Plasma Inc. - April 09, 2026

Source: https://www.keypedia.com/records/483/csl-plasma-inc/baf9b30b-b26a-4e5a-a400-113dcd29fd4f

> FDA 483 for CSL Plasma Inc. on April 09, 2026. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: CSL Plasma Inc.
- Inspection Date: 2026-04-09
- Product Type: biologics
- Office Name: Detroit District Office
- Summary: An FDA inspection of CSL Plasma Inc. in Whitestown, IN, a source plasma storage and distribution facility, revealed significant compliance issues. The firm failed to submit a biological product deviation report within 45 days for inappropriately distributed plasma. Additionally, the company did not properly label source plasma units that tested reactive for transfusion-transmitted infections or correctly relabel plasma exposed to inappropriate temperatures as "Source Plasma Salvaged."

## Related Officers

- [Lesley Mae P. Lutao](https://www.keypedia.com/people/lesley-mae-p-lutao/bfdcc755-28e5-4caf-91f9-b9579df4731e)

Company: https://www.keypedia.com/companies/csl-plasma-inc/abb7bd1c-ee97-47d8-8e5b-d54c2d1fec68

Office: https://www.keypedia.com/offices/detroit-district-office/b09a1815-a000-40c0-bb44-5432ce87ed03