The FDA inspected Masimo’s Irvine, Calif., facility from August to October last year and issued a Form 483 detailing several complaint procedure violations, according to a regulatory filing.
The August 12 warning letter flagged Masimo for failing to "review, evaluate, and investigate complaints involving the possible failure of a device to meet any of its specifications," according to the filing, citing customer complaints "regarding inaccurate readings of the Pronto 7 devices."
"Your review of these complaints failed to adequately evaluate and investigate the inaccurate readings. Your firm’s documented reviews failed to identify the comparator that was used, if any, to verify the accuracy of the device’s readings and failed to evaluate the device at the range of hemoglobin readings that were the subject of the complaints. By not evaluating the complaints using appropriate parameters, the results of your complaint analyses may be compromised and may lead to improper corrective action plans," according to the letter.
The letter also called out failures to keep adequate complaint records and to establish and maintain corrective measures. Masimo said it’s already working on a response to the warning letter.
"Masimo takes the matters identified in the warning letter seriously and is in the process of evaluating what corrective actions, and associated costs, may be required to address the matters raised in the warning letter. Masimo is also in the process of preparing a response to the warning letter and intends to respond fully to the issues raised by the FDA within 15 business days as requested by the FDA and to work expeditiously to address those issues," according to the filing. "The warning letter does not restrict the manufacture, production or shipment of any of Masimo’s devices, nor require the withdrawal of any product from the marketplace. Masimo will diligently work with the FDA to resolve the issues raised in the warning letter. However, failure to promptly address the issues raised in the warning letter to the FDA’s satisfaction or to comply with U.S. medical device regulatory requirements in general could result in regulatory action being initiated by the FDA. These actions could include, among other things, product seizures, injunctions and civil money penalties."