Masimo Corporation
Form 483 issued October 3, 2013 · Irvine, California
- Inspection
- Oct 3, 2013
- Investigator
- Kirtida Patel
- Observations
- 9
- Pages
- 11
- FEI number
- 3001452206
In short: On October 3, 2013, FDA issued a Form 483 with 9 observations to Masimo Corporation in Irvine, California (FEI 3001452206) after an inspection that ran Oct 3, 2013. The investigator was Kirtida Patel. Most observations concern cAPA and design controls; the most-cited regulation is 21 CFR 820.198 (complaint files).
At a glance
6 of 9 observations on this 483 concern capa.
What FDA observed
Preview: the opening words of each observation- 01
Complaints involving the possible failure of a device to meet any of its specifications were not…
- 02
An MDR report was not submitted within 30 days of receiving or otherwise becoming aware of…
- 03
Records of complaint investigations do…
- 04
Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have…
This inspection in context
Kirtida Patel
4 documents · 2008–2020
Cites 820.198(a) (complaint files) more than any other section. Most of their documents are for sites in California.
The firmMasimo Corporation history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 820.198(c)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Masimo Corporation?
FDA listed 9 observations on this Form 483, mostly about cAPA, design controls and production & process controls. The most-cited regulation is 21 CFR 820.198 (complaint files). The opening words of each observation are shown on this page.
Who inspected Masimo Corporation?
Kirtida Patel is named on this Form 483, for the inspection of Oct 3, 2013. Each investigator has a profile showing what they cite most.
When was Masimo Corporation inspected by FDA?
The inspection ran Oct 3, 2013, and the Form 483 is dated October 3, 2013.
How do I get the full Form 483 for Masimo Corporation?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.