The FDA sent medical device manufacturer XZeal Technologies a Form 483, citing issues with design validation and medical device reporting procedures.
In an October 2016 inspection of the company’s Kissimee, Florida facility, the FDA found XZeal’s design validation process for its Z70 Dental X-Ray device user manual did not ensure that installation instructions were validated for all users that may install the device. For example, design validation activities were conducted using only technicians from device distributors and did not include dentists.
In addition, the company’s medical device reporting procedures were observed to be inadequate because they did not contain instructions for conducting a complete investigation of each event and evaluating the cause. — Jeff Kinney