General Devices, a maker of mobile telemedicine systems, has been warned for not finding the root causes of problems or documenting complaint evaluations.
During a 2015 inspection of the Ridgefield, N.J., company, the FDA found an unsigned standard operating procedure on its corrective and preventive actions policy. The SOP did not require root cause investigations for:
The CAPA policy also did not require the company to analyze various quality data to find the causes of nonconforming products or recurring problems, according to the June 1 letter posted to the FDA’s website June 7.
A review of service records from March 4, 2013, to June 2, 2015, showed that certain Carepoint EMS Workstation monitors were sent to suppliers to be exchanged following malfunctions, but the company didn’t conduct a CAPA investigation to find the root cause of the malfunctions, the letter says.
The FDA also cited the company for its medical device reporting SOP, which did not require an internal system to identify and evaluate events for medical device reportability.
Another unsigned SOP — this time on the change notification system — did not require the company to verify or validate design changes before implementation. These changes included new versions and upgrades of software.