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Home » New York Facility Cited for Lax Complaint Reporting, CAPA Failures
New York Facility Cited for Lax Complaint Reporting, CAPA Failures
Graphic Controls Data Recording failed to inform the FDA of several complaints about its automatic external defibrillator (AED) pads malfunctioning in a way that could have caused serious injury or death to patients, agency investigators found during an inspection of the company’s Buffalo, N.Y. facility.