483
B Positive National Blood Services - Cheltenham, LLCB Positive National Blood Services - Cheltenham, LLC – FDA 483, Aug 24, 2022
Record Details
B Positive National Blood Services - Cheltenham, LLC, a plasma center, was cited with two observations during an FDA inspection. The firm failed to ensure that the responsible physician approved the reinstatement of deferred donors with abnormal protein test results. Additionally, the facility did not store reagents and supplies according to manufacturer instructions or monitor their storage temperatures.
- Inspection date
- August 24, 2022
- Product type
- biologics
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ID · 6006e660-aed4-43f3-8065-624c24ed00b5
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