FDA issues warning to Mindray
Mindray is in the crosshairs of the FDA again. China's largest medical device company received a Nov. 29 warning letter for several quality system violations.
The FDA cited Mindray over manufacturing problems with its patient monitors and other equipment. Allegations include Mindray replacing at least 17 units of its V-Series monitors with touch screens at the end of 2011 and through mid-2012 that failed to work, disabling the interface. The FDA said the company hadn't taken any effort to make corrections or evaluate the actions that suppliers took to initially fix the problem.
The company failed to conduct sufficient investigations regarding a number of failed monitor modules and faulty software. Also, company managers fell short in establishing procedures to handle complaints regarding device, labeling or packaging failures, and also in how they put together reports documenting those problems.
The FDA previously warned Mindray which led the company to enact a voluntary recall of its A3/A5 Anesthesia Delivery System, warning that the devices could possibly leak CO2.