# FDA 483 - CSL Plasma Inc. - December 01, 2025

Source: https://www.keypedia.com/records/483/csl-plasma-inc/a631303f-fb3b-45fa-a2de-017990f73d5c

> FDA 483 for CSL Plasma Inc. on December 01, 2025. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: CSL Plasma Inc.
- Inspection Date: 2025-12-01
- Product Type: biologics
- Office Name: Office of Regulatory Affairs
- Summary: CSL Plasma Inc. in District Heights, MD, received a Form 483 with two observations during an inspection. The firm failed to prevent the release of unsuitable Source Plasma units for further manufacturing from donors with unconfirmed failed test results. Additionally, the company did not adequately notify donors of positive test results for transfusion-transmitted infections, including HIV, HCV, and HBV.

## Related Documents

- [483 - 2025-12-01](https://www.keypedia.com/records/483/csl-plasma-inc/3aa2c14a-a1c5-43d0-bf41-b1e6f4a2dc6b)

## Related Officers

- [La-tasha M. Gunter](https://www.keypedia.com/people/la-tasha-m-gunter/db9cd9cf-db0a-4c31-9f7c-24760750f34d)

Company: https://www.keypedia.com/companies/csl-plasma-inc/2271b6f1-b059-4de5-9e2d-1f39b776ab7b

Office: https://www.keypedia.com/offices/office-of-regulatory-affairs/ff91c598-cf72-4dbe-a2c8-7519c64cbc64