483
North Shore Medical CenterNorth Shore Medical Center – FDA 483, Jul 2, 2019
Record Details
The FDA inspected North Shore Medical Center, a blood bank in Salem, MA, and issued a Form 483. The inspection revealed a significant deficiency in the firm's written standard operating procedures concerning the storage and distribution of blood and blood components. Specifically, the facility lacked a procedure for documenting pathologist approval for the emergency use of outdated platelets.
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ID · af631aa6-fe3e-49c8-9c7a-959e4b400312
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