FDA 483 - Allied Medical LLC - October 30, 2024

Allied Medical LLC, a medical device manufacturer in Saint Louis, MO, received a Form FDA 483 with five observations during an inspection from October 22-30, 2024. The firm was cited for significant quality system deficiencies, including unsanitary facility conditions, unvalidated manufacturing processes for transport ventilators, and inadequate corrective and preventive action procedures. Additionally, the inspection revealed failures in supplier qualification and a severe lack of timely Medical Device Report (MDR) submissions for serious injuries and a death.