Company
United StatesMasimo Corporation, Irvine, CA – FDA Inspections
Inspection records and compliance data for Masimo Corporation in Irvine, California. 5 FDA inspections on record (1 OAI), last inspected September 13, 2018.
Company Profile
This profile covers Masimo Corporation based in Irvine, California, United States.
FDA Inspection History
- FDA inspections
- 5
- OAI
- 1
- VAI
- 0
- NAI
- 4
- Form 483s
- 0
- Warning letters
- 0
First inspected February 3, 2010. Last inspected September 13, 2018.
Most cited issue areas
- Design verification - output does not meet input requirement1 inspection
- Documentation1 inspection
- Investigation of device failures1 inspection
FDA inspections (5)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| September 13, 2018 | NAI | Medical Devices & Rad Health · Bioresearch Monitoring | 1067514 |
| May 5, 2017 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1011370 |
| October 3, 2013 | OAI | Medical Devices & Rad Health · Compliance: Devices | 851391 |
| February 11, 2011 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 711962 |
| February 3, 2010 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 649261 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Masimo Corporation
FEI Number
3001452206
Address
52 Discovery, Irvine, California 92618, United States
Country
United States
ID: c75ae729-c637-4038-be29-01fce47906c3