Customer Services Associates received a Form 483 for not developing written medical device reporting procedures, establishing procedures for corrective actions and reviewing complaints, and other violations.
During an October inspection of the company’s Winchester, Ind., facility, inspectors found that Customer Services had not developed and maintained written MDR procedures. Specifically, there were no procedures for identifying, communicating, and evaluating events that maybe subject to MDR requirements; timely transmitting complete MDRs to the FDA; and keeping appropriate records.
The inspectors also found that Customer Services Associates had not established corrective and preventive action (CAPA) procedures, including ones that specified when quality issues would result in CAPA actions. For example, between May 2014 and September 2016, the firm received 76 complaints related to its blood pressure monitoring kiosk. Thirty of these complaints were attributed to a cuff leak, but further investigation of the root cause was not elevated to a CAPA.
The company also failed to document labeling inspections for blood pressure kiosks, including inspections for accuracy and final release of the labels. Additional violations included an inadequate device record, failure to specify where rework activities and subsequent inspection were documented, and failure to maintain records that justified not reporting a correction and removal action to the FDA.