483
B Positive National Blood ServicesFDA 483 - B Positive National Blood Services
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Record Details
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.
- Product Type
- Biologics
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ID · ad7327f6-9fa8-477b-ab88-36e25a5228f8