The federal safety watchdog sent the letter in August 2014 after inspections in August to October 2013, flagging Masimo for failing to “review, evaluate, and investigate complaints involving the possible failure of a device to meet any of its specifications,” citing customer complaints “regarding inaccurate readings of the Pronto 7 devices.”
The letter also called out failures to keep adequate complaint records and to establish and maintain corrective measures, Masimo said in a regulatory filing.
Yesterday Masimo said it received a letter from the FDA May 26 “indicating that FDA has completed an evaluation of Masimo’s corrective actions in response to the warning letter, and that, based on the FDA’s evaluation, it appears that Masimo has addressed the violations contained in the warning letter.”
“Based on our evaluation, it appears that you have addressed the violations(s) contained in this warning letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of theses corrections,” Kelly Sheppard, acting program division director at the FDA’s western division of the Office of Medical Device and Radiological Health Operations, wrote in the May 25 letter. “The agency expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.”