# FDA 483 - BPL Plasma, Inc. - May 20, 2019

Source: https://www.keypedia.com/records/483/bpl-plasma-inc/c9403753-6478-40e3-a256-f8ca74d178f7

> FDA 483 for BPL Plasma, Inc. on May 20, 2019. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: BPL Plasma, Inc.
- Inspection Date: 2019-05-20
- Product Type: biologics
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: BPL Plasma, Inc. in El Paso, TX, was cited for three observations related to donor management and equipment procedures during an FDA inspection. The firm failed to notify donors of all infectious disease test results and did not follow its SOP for donor counseling. Additionally, the firm did not consistently adhere to manufacturer instructions for apheresis instrument cleaning and calibration, and improperly removed donor deferrals for adverse events without required follow-up.

## Related Officers

- [Judy Ciaraldi](https://www.keypedia.com/people/judy-ciaraldi/118700d5-700a-44bf-a19f-64486c2d0725)
- [Christopher Sy](https://www.keypedia.com/people/christopher-sy/429ca249-f950-43cc-b055-4b9b93bfba18)

Company: https://www.keypedia.com/companies/bpl-plasma-inc/9c04b979-677a-4cf8-9e3c-66f8b5b4935e

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