FDA WARNING_LETTER - MASIMO CORPORATION - October 03, 2013

An FDA inspection of Masimo Corporation in Irvine, CA, from August to October 2013, found their Rainbow SET Pronto-7 Pulse CO-Oximeter and Rad-8 Signal Extraction Pulse Oximeter devices adulterated. The firm's manufacturing methods, facilities, or controls did not conform to the Quality System regulation (21 CFR Part 820). Key violations included the failure to adequately review, evaluate, and investigate device complaints (21 CFR 820.198(c)), and complaint investigation records lacked required details (21 CFR 820.198(e)). Furthermore, Masimo failed to establish and maintain adequate corrective and preventive action (CAPA) procedures, specifically in identifying all potentially affected nonconforming products (21 CFR 820.100(a)(3)) and thoroughly investigating the cause of nonconformities (21 CFR 820.100(a)(2)). The firm's Medical Device Reporting (MDR) procedure also contained an inadequate definition of "caused or contributed" to a serious injury or death, not aligning with 21 CFR 803.3. The company's responses to the FDA 483 observations were deemed inadequate. Masimo must promptly correct these violations and provide a written response within fifteen working days, detailing corrective actions, prevention plans, and a timetable. Failure to comply may result in regulatory actions like seizure, injunction, civil money penalties, and impact on federal contracts. A regulatory meeting was requested.