ZOLL Medical Corporation – FDA 483, Mar 18, 2011

An FDA inspection of ZOLL Medical Corporation in Chelmsford, MA, a medical device manufacturer, revealed significant deficiencies across multiple quality system areas. The firm failed to adequately validate device designs and software, manage corrective and preventive actions, and maintain an effective device tracking program. Additionally, issues were noted in complaint handling, training procedures, and control of non-conforming materials, including components related to a Class I Recall.