The FDA is closing out a warning letter sent to Intuitive Surgical (NSDQ:ISRG) last year over problems with its adverse event reporting system.
Sunnyvale, Calif.-based Intuitive said today that "based on the FDA’s evaluation, it appears that the Company has addressed the violations contained in the warning letter."
The federal watchdog agency last year sent the warning letter after inspections of an Intuitive facility found 4 problems with how the company handled "field actions," or corrective actions taken when a problem is discovered with its da Vinci line of robotic surgery systems.
"These 4 observations relate to the reporting of field actions, information which is to be included on reports of field actions, lack of a written procedure for changes to certain product claims, and design input documentation," Intuitive said at the time. "In addition, the FDA collected in electronic form, samples of all advertising and promotional material for review."
Since then Intuitive’s steps to correct the problems have put the FDA’s concerns to rest, according to a regulatory filing.
"The Food & Drug Administration has completed an evaluation of your firm’s corrective actions in response to our warning letter," the agency said in the April 25 letter. "Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections."
