# FDA 483 - CSL Plasma Inc. - August 05, 2019

Source: https://www.globalkeysolutions.net/records/483/csl-plasma-inc/809140b6-e371-46e3-aff1-88713746516b

> FDA 483 for CSL Plasma Inc. on August 05, 2019. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: CSL Plasma Inc.
- Inspection Date: 2019-08-05
- Product Type: biologics
- Office Name: Philadelphia District Office
- Summary: CSL Plasma, Inc. in Philadelphia, PA, was cited for significant deficiencies in donor screening and eligibility determination processes, including the use of incorrect gender-specific health history questionnaires. The inspection also revealed a failure to thoroughly investigate a trend of plasma overharvests and a failure to submit required biological product deviation reports. These issues indicate serious concerns regarding donor safety and product quality control.

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/csl-plasma-inc/d5a1ee4e-6799-42de-9914-7a7db838be72

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