# FDA 483 - CSL Plasma, Inc. - Unknown Date

Source: https://www.keypedia.com/records/483/csl-plasma-inc/20168526-087a-497a-8015-5bc83da4ce4d

> 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 Rochester, New York, was cited for deficiencies in its plasmapheresis operations. The inspection revealed that serologic tests for syphilis and protein electrophoresis were not consistently performed on the day of initial donation, leading to unsuitable units not being identified. Additionally, the firm failed to ensure timely and complete donor notification of all test results and lacked adequate written procedures for this process.

## Related Officers

- [Judy Ciaraldi](https://www.keypedia.com/people/judy-ciaraldi/118700d5-700a-44bf-a19f-64486c2d0725)
- [Investigator](https://www.keypedia.com/people/anthony-n-onianwa/910dd164-8542-4259-b11f-ea3a3f6d7baa)

Company: https://www.keypedia.com/companies/csl-plasma-inc/a918a90d-4a02-4a5c-abad-cd0a4e08c334

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