FDA 483 - Blood Bank of Alaska, Inc. - March 22, 2019

The FDA inspected Blood Bank of Alaska, Inc. in Anchorage, AK, and issued a Form 483 with two observations. The inspection revealed issues with the proper storage of red blood cells, where units were found to be stored above the acceptable temperature range, and a failure to consistently follow written standard operating procedures for donor identification, resulting in duplicate donor IDs for two individuals. These findings indicate deficiencies in temperature control and adherence to established procedures for blood product handling and donor management.