Edwards Lifesciences, LLC
FDA inspection history across 2 sites, 2010 to 2016
- 2
- Form 483s
- 2
- Warning letters
- 1
- Close-out
Every document, by year
- Close-out
- Form 483
- Warning letter
2010: one warning letter; 2013: one warning letter; 2014: one Form 483; 2015: one Form 483; 2016: one close-out letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2010One warning letter, at Irvine, California.
- 2013–16Two Form 483s, one warning letter and one close-out letter, at Irvine, California and Draper, Utah.
- 2014The longest 483 on file: 13 observations over 20 pages at Draper, Utah.
Cited most
Across all Edwards Lifesciences observations on file
- 21 CFR 820.90Nonconforming product3
- 21 CFR 820.100Corrective and preventive action2
- 21 CFR 820.184Device history record2
- 21 CFR 820.70Production and process controls2
- 21 CFR 820.75Process validation2
The complete Edwards Lifesciences file.
All 5 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
15% off buying them one by one
Sites
Irvine, California
Two warning letters and one close-out letter · 2010 to 2016
Latest: Close-out, Jul 6, 2016 →Draper, Utah
Two Form 483s · 2014 to 2015 · 18 observations
Latest: Form 483, Nov 20, 2015 →
Documents
5 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2016-07-06 | Close-out Close-out letter | Irvine, California | — | $99 |
| 2015-11-20 | 483 Form 483 | Draper, Utah | 5 | $99 |
| 2014-04-11 | 483 Form 483 | Draper, Utah | 13 | $99 |
| 2013-05-24 | Warning letter Warning letter | Irvine, California | — | $99 |
| 2010-03-12 | Warning letter Warning letter | Irvine, California | — | $99 |
Investigators on these documents
James R. Montero (2)Amanda S. Zorn (1)Janet Pulver (1)Sean T. Creighton (1)Thai Duong (1)
FEI number 1713910 · most recent document Jul 6, 2016
About Edwards Lifesciences, LLC
How many FDA Form 483s has Edwards Lifesciences, LLC received?
FDA Intel has 2 Form 483s on file for Edwards Lifesciences, LLC; the most recent is dated Nov 20, 2015.
When was Edwards Lifesciences, LLC last inspected by FDA?
The most recent FDA inspection document on file for Edwards Lifesciences, LLC is a Form 483 dated Nov 20, 2015, for the site in Draper, Utah.
What did FDA cite at Edwards Lifesciences, LLC?
The regulations cited most in the observations on file for Edwards Lifesciences, LLC are 21 CFR 820.90 (Nonconforming product), 3 times; 21 CFR 820.100 (Corrective and preventive action), 2 times; 21 CFR 820.184 (Device history record), 2 times.
Has Edwards Lifesciences, LLC received an FDA warning letter?
Yes. FDA Intel has 2 FDA warning letters on file for Edwards Lifesciences, LLC; the most recent is dated May 24, 2013.