FDA 483 - The Children's Hospital Corporation - February 14, 2017

An FDA inspection of Boston Children's Hospital's Blood Bank identified three observations related to failures in following written standard operating procedures for blood and blood component collection. These failures included inadequate donor health history screening for travel-related risks, not checking deferral lists, and incomplete documentation for platelet apheresis donors. The observations indicate a lack of adherence to established protocols for ensuring donor eligibility.