FDA 483 - ARUP Laboratories Inc. - March 11, 2019
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ARUP Laboratories, Inc. in Salt Lake City, Utah, a hospital transfusion service, received a Form 483 with five observations. The inspection revealed issues with recordkeeping for emergency transfusions, failure to follow and establish adequate standard operating procedures for blood product processing and storage, and deficiencies in facility temperature control for platelet handling. These observations indicate significant concerns regarding quality control and adherence to established protocols in blood product management.
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