# FDA 483 - CSL Plasma Inc. - May 02, 2019

Source: https://www.keypedia.com/records/483/csl-plasma-inc/a2097c05-4ae8-4d4a-9480-bdb4b16580fd

> FDA 483 for CSL Plasma Inc. on May 02, 2019. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: CSL Plasma Inc.
- Inspection Date: 2019-05-02
- Product Type: biologics
- Office Name: Philadelphia District Office
- Summary: CSL PLASMA in Philadelphia, PA, was inspected from April 16 to May 2, 2019, revealing a significant issue regarding the presence of medical staff. The firm failed to ensure a responsible physician or physician substitute was on the premises during critical donor eligibility determinations and blood collection activities. This indicates a lapse in direct medical oversight for source plasma operations.

## Related Officers

- [Nikisha Rolden](https://www.keypedia.com/people/nikisha-rolden/ccd5f87b-fb28-493d-b0a5-2ebde50461be)
- [investigator](https://www.keypedia.com/people/erika-m-wilkerson/cd1c299d-c827-4d52-8e2b-719989da9991)

Company: https://www.keypedia.com/companies/csl-plasma-inc/e24fce70-7c46-4cae-934e-4e4d4f4c76d9

Office: https://www.keypedia.com/offices/philadelphia-district-office/c5ec7398-b3d5-4125-9793-fb7b972578d8