# FDA 483 - B Positive National Blood Services - Wilkes Barre, LLC - October 29, 2025

Source: https://www.keypedia.com/records/483/b-positive-national-blood-services-wilkes-barre-llc/e69b2f14-a380-48e4-914c-f58c9b52ca87

> FDA 483 for B Positive National Blood Services - Wilkes Barre, LLC on October 29, 2025. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: B Positive National Blood Services - Wilkes Barre, LLC
- Inspection Date: 2025-10-29
- Product Type: biologics
- Office Name: FDA District Office — Philadelphia, Pennsylvania
- Summary: An FDA inspection of B Positive National Blood Services - Wilkes Barre, LLC in Edwardsville, PA, a Source Plasma Donor Center, revealed significant deficiencies. Observations included a failure to document quality control checks for equipment, inadequate notification of deferred donors with reactive HCV test results, and unsanitary practices for the disposal of waste from blood collection. These issues highlight concerns with the firm's adherence to regulatory requirements for documentation, donor safety, and facility sanitation.

## Related Officers

- [Michele Gottshall](https://www.keypedia.com/people/michele-gottshall/f12dcaf7-8958-4591-88bb-f9746796b934)

Company: https://www.keypedia.com/companies/b-positive-national-blood-services-wilkes-barre-llc/3f4c5231-5f89-437a-b9af-2175e9cbf937

Office: https://www.keypedia.com/offices/fda-district-office-philadelphia-pennsylvania/e70a6e70-40b2-49e4-8360-c3db36c4d2a0