Masimo Corporation
FDA inspection history in Irvine, California, 2013 to 2017
- 1
- Close-out
- 1
- Form 483
Every document, by year
- Close-out
- Form 483
2013: one Form 483; 2017: one close-out letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2013One Form 483, at Irvine, California.
- 2017One close-out letter, at Irvine, California.
Cited most
Across all Masimo observations on file
- 21 CFR 820.198(a)Complaint files3
- 21 CFR 820.100(a)Corrective and preventive action2
- 21 CFR 803.50(a)(1)If I am a manufacturer, what reporting requirements apply to me?1
- 21 CFR 820.186Quality system record1
- 21 CFR 820.22Quality audit1
The complete Masimo file.
All 2 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Irvine, California
One close-out letter and one Form 483 · 2013 to 2017 · 9 observations
Latest: Close-out, May 22, 2017 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2017-05-22 | Close-out Close-out letter | Irvine, California | — | $99 |
| 2013-10-03 | 483 Form 483 | Irvine, California | 9 | $99 |
Investigators on these documents
FEI number 3001452206 · most recent document May 22, 2017
About Masimo Corporation
How many FDA Form 483s has Masimo Corporation received?
FDA Intel has 1 Form 483 on file for Masimo Corporation; the most recent is dated Oct 3, 2013.
When was Masimo Corporation last inspected by FDA?
The most recent FDA inspection document on file for Masimo Corporation is a Form 483 dated Oct 3, 2013, for the site in Irvine, California.
What did FDA cite at Masimo Corporation?
The regulations cited most in the observations on file for Masimo Corporation are 21 CFR 820.198(a) (Complaint files), 3 times; 21 CFR 820.100(a) (Corrective and preventive action), 2 times; 21 CFR 803.50(a)(1) (If I am a manufacturer, what reporting requirements apply to me?), 1 time.