FDA 483 - The General Hospital Corporation - April 28, 2014

The General Hospital Corporation's blood bank in Boston, MA, was cited for multiple significant violations during an FDA inspection. These issues include the unauthorized extension of platelet expiration dates, failure to ensure physician certification of donor health, and inadequate record review for previously donated blood components, including HIV lookbacks. Additionally, the firm was cited for improper phlebotomy site preparation and untimely submission of biological product deviation reports.