FDA 483 - O&M HALYARD INC - April 27, 2023

O&M HALYARD INC in Alpharetta, GA, a medical device specification developer, was cited for failing to submit Medical Device Reports (MDRs) in a timely manner. The firm did not report multiple complaints regarding N95 Respirator elastic bands breaking during use, which could lead to serious injury if the malfunction were to recur, potentially exposing healthcare workers to COVID-19.