483
American Red Cross Blood Services Southwest RegionFDA 483 - American Red Cross Blood Services Southwest Region - January 31, 2019
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Record Details
An FDA inspection of American Red Cross Blood Services Southwest Region in Dallas, TX, identified one observation related to the improper storage of Whole Blood collection sets. The firm failed to follow manufacturer's instructions for storing these sets with Red Cell preservative solution at a controlled room temperature. This indicates a failure to adhere to proper supply and reagent handling procedures.
- Inspection Date
- January 31, 2019
- Product Type
- Biologics
- Office
- Dallas District Office
- Person
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ID · c3e95603-0d67-4503-923b-929421f46eb1