483
American National Red Cross (The), Lewis and Clark RegionFDA 483 - American National Red Cross (The), Lewis and Clark Region - March 31, 2023
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Record Details
The FDA inspected American National Red Cross (The), Lewis and Clark Region in Salt Lake City, UT, from March 20-31, 2023. The inspection revealed a significant issue with record-keeping practices, specifically concerning the documentation of blood products removed from controlled storage. This lapse resulted in units of Leukocyte Reduced Red Blood Cells exceeding their allowed out-of-storage temperature limits.
- Inspection Date
- March 31, 2023
- Product Type
- Biologics
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