FDA Inspection
Masimo CorporationMasimo Corporation – FDA Inspection, Oct 3, 2013
Record Details
This FDA Inspection record concerns Masimo Corporation, with an inspection on October 3, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Masimo Corporation
- Inspection Date
- October 3, 2013
- Product Type
- Devices
View Company Profile
ID · 95198fd2-44ba-4d81-88fa-84c473b8a7c1
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 851391
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
9- 21 CFR 803.50(a)(1)Report of Death or Serious Injury
- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.30(f)Design verification - output does not meet input requirement
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.198(e)Records of complaint investigation
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Masimo Corporation
4| Date | Classification | Office | Project area |
|---|---|---|---|
| September 13, 2018 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
| May 5, 2017 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 11, 2011 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| February 3, 2010 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Masimo Corporation
- FDA Inspection 1067514 - 2018-09-13
- FDA Inspection 1011370 - 2017-05-05
- FDA Inspection 711962 - 2011-02-11
- FDA Inspection 649261 - 2010-02-03
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