Columbia Scientific Development did not properly investigate potential device failures or develop written MDR procedures, according to the FDA.
The agency issued a Form 483 following a May/June inspection of the medical device specifications developer’s Portland, Ore., facility. Investigators found Columbia’s complaint handling procedure did not require investigating complaints involving possible failures of devices, their labeling or their packaging. Two of four complaints documented since May 2016 related to potential problems with the company’s electrode devices, but the company documented that both were closed without an investigation.
The FDA faulted the company’s MDR procedures, noting that it did not have an internal system for identifying and submitting supplemental or follow-up reports or submitting MDR events to the agency.