FDA issued a Warning Letter to Masimo Corporation on 8/12/2014 as a result of this inspection.
FDA investigators audited the Masimo - Irvine, CA, United States facility and issued 9 inspectional observations (via FDA 483) on 03 Oct 2013.
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- Category: Medical Devices & Rad Health
- Number of Observations: 9
- Inspection end: 03 Oct 2013
- Location: Irvine, United States
- FEI: 3001452206