FDA EIR - AccessClosure, Inc., A Cardinal Health Company - September 15, 2017

An FDA inspection of AccessClosure, Inc., A Cardinal Health Company, in Santa Clara, CA, took place from September 7 to September 15, 2017. This routine quality system inspection, conducted under the guidance of the Quality System Inspection Technique (QSIT) and relevant FDA compliance programs for medical device manufacturers, focused on the firm's corrective and preventive actions (CAPA) and production and process controls for its Class III vascular access closure devices. The main violation identified was the inadequate establishment and implementation of procedures for receiving, reviewing, and evaluating complaints. Specifically, the company did not sufficiently collect event details, patient information, and device specifics for complaint files, nor did it adequately document efforts to retrieve devices for investigation. Follow-up attempts to obtain missing information were found to be insufficient and not properly documented, leading to incomplete Medical Device Reports (MDRs). This observation was cited under 21 CFR 820.198(a) on a Form FDA 483. In response, management committed to correcting the deficiencies and submitting a written action plan to the FDA within 15 business days, including a timeframe for implementation.