FDA 483 - ZOLL Medical Corporation - April 15, 2025

ZOLL Medical Corporation in Chelmsford, MA, received a Form 483 with five observations highlighting significant deficiencies in their quality system. The inspection revealed inadequate procedures for design validation, corrective and preventive actions, risk analysis, and supplier management, leading to multiple product recalls, serious injuries, and deaths. Additionally, the firm failed to submit required Medical Device Reports (MDRs) for device malfunctions.