Lithuanian devicemaker Telemed landed an FDA warning letter when it failed to satisfy the agency with responses to problems identified during a July-August inspection of the firm’s Vilnius facility.
The agency found that the firm lacked an adequate design plan for its 2013-2015 MicrUS ultrasound imaging system. Telemed acknowledged the design plan template should comply with revised design control procedures, but it did not say how it would correct the issues or provide a design plan procedure for the FDA to review.
The FDA also faulted the facility for its complaint procedures, which did not include elements required for an investigation record, including a definition of what is considered a complaint or a medical device reporting determination. A review of 12 complaint records between April 2016 and May 2017 found no MDR determinations for any complaints or any reply to the complainant.