# CSL Plasma, Inc. – FDA 483, Jul 20, 2026

Source: https://www.keypedia.com/records/483/csl-plasma-inc/b3d82547-728a-401a-8e25-777100a8fb37

> FDA 483 for CSL Plasma, Inc. on July 20, 2026. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: CSL Plasma, Inc.
- Inspection Date: 2026-07-20
- Product Type: biologics
- Office Name: New York District Office
- Summary: CSL Plasma Inc. in Rochester, NY, was inspected regarding its source plasma operations and received one observation. The firm was cited for inadequate staffing levels during apheresis collection, specifically failing to meet the required phlebotomist-to-donor ratio outlined in their standard operating procedures. This deficiency raises concerns about the safety, purity, potency, identity, and effectiveness of the final product.

## Related Documents

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

## Related Officers

- [Jennifer L. Diaz](https://www.keypedia.com/people/jennifer-l-diaz/02f69ae1-5daf-45bc-8047-84e302e5c68d)
- [investigator](https://www.keypedia.com/people/randy-l-clarida/aae3cc15-a908-4489-9299-7542370ad3cd)

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

Office: https://www.keypedia.com/offices/new-york-district-office/9fa3d265-16ca-438d-8a6e-b47f60dc260d
