The FDA sends a warning letter to Masimo, saying the company doesn't have procedures in place to adequately investigate and document device failure complaints for its Pronto 7 pulse oximeter. FDA warns Masimo on inadequate complaint reviews
Masimo (NSDQ:MASI) said it received a warning letter yesterday from the FDA over its procedures for reporting and investigating failure complaints for its Pronto 7 pulse oximeters.
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.
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