FDA 483 - Novant Health Forsyth Medical Center - May 02, 2024

An FDA inspection of Novant Health Forsyth Medical Center's Hospital Transfusion Service Facility in Winston Salem, NC, revealed issues with recordkeeping for emergency transfusions. Specifically, the facility failed to consistently maintain records with physician signatures for emergency release procedures. This indicates a moderate concern regarding compliance with record maintenance requirements for critical medical procedures.