# CSL Plasma Inc. – FDA 483, Jun 17, 2026

Source: https://www.keypedia.com/records/483/csl-plasma-inc/e7fba662-d337-4543-86a9-c0592358b985

> FDA 483 for CSL Plasma Inc. on June 17, 2026. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: CSL Plasma Inc.
- Inspection Date: 2026-06-17
- Product Type: biologics
- Office Name: Detroit District Office
- Summary: An FDA inspection of CSL Plasma Inc. in Mishawaka, IN, revealed a significant issue regarding the failure to follow manufacturer instructions for quality control procedures. Specifically, staff did not properly perform quality control on a refractometer, which is a repeat observation from a previous discussion item. This indicates a moderate concern regarding adherence to established protocols for equipment usage.

## Related Officers

- [Gabryelle J. Solverud](https://www.keypedia.com/people/gabryelle-j-solverud/29c4452f-2f7a-4325-8f8d-7046fcb4690f)
- [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/a55a0a49-905e-4b46-8919-533965159806

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