# FDA 483 - B Positive National Blood Services - Unknown Date

Source: https://www.keypedia.com/records/483/b-positive-national-blood-services/ad7327f6-9fa8-477b-ab88-36e25a5228f8

> FDA 483 for B Positive National Blood Services on Unknown Date. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: B Positive National Blood Services
- Product Type: biologics
- Office Name: Office of Medical Device and Radiological Health Operations
- Summary: An FDA inspection of B Positive National Blood Services in Easton, Pennsylvania, from November 5-7, 2024, revealed two significant observations. The firm failed to recalibrate a critical device used for quality control checks of collection equipment and did not conduct a required performance qualification study for freezers used to store Source Plasma units prior to their use.

## Related Documents

- [483 - Unknown Date](https://www.keypedia.com/records/483/b-positive-national-blood-services/c9819925-ff21-4325-aa09-cf12c74c712f)

## Related Officers

- [Michelle D. Gutierrez](https://www.keypedia.com/people/michelle-d-gutierrez/b6117afc-1a01-41b0-a0e6-6aeb33935968)
- [Dionne L. Cook](https://www.keypedia.com/people/dionne-l-cook/37169bb2-3350-413d-accb-5454cfcbca62)

Company: https://www.keypedia.com/companies/b-positive-national-blood-services/3d244d36-0bea-4c54-8003-7af8764ed4b5

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-operations/27658190-735a-443e-9087-3534cfe74fd4