North Shore Medical CenterJuly 2, 2019

FDA 483 - North Shore Medical Center - July 02, 2019

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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 Specifically, the facility lacked a procedure for documenting pathologist approval for the emergency use of outdated platelets.

Company: North Shore Medical Center
Inspection Date: July 2, 2019
Product Type: Biologics
Office: Division of Northeast Imports
Person: Alice Silva (Investigator)

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ID · af631aa6-fe3e-49c8-9c7a-959e4b400312