Edwards Lifesciences, LLC
Form 483 issued April 11, 2014 · Draper, Utah
- Inspection
- Mar 3 – Apr 11, 2014
- Investigators
- Amanda S. Zorn· James R. Montero· Janet Pulver
- Observations
- 13
- Pages
- 20
- FEI number
- 1713910
In short: On April 11, 2014, FDA issued a Form 483 with 13 observations to Edwards Lifesciences, LLC in Draper, Utah (FEI 1713910) after an inspection that ran Mar 3 – Apr 11, 2014. The investigators were Amanda S. Zorn, James R. Montero, Janet Pulver and Sean T. Creighton. Most observations concern production & process controls and cAPA; the most-cited regulation is 21 CFR 820.100 (corrective and preventive action).
At a glance
Production & process controls and capa account for 12 of 13 observations.
Most cited: 21 CFR 820.100 (2×) · 820.70 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
A process whose results cannot be fully verified by subsequent inspection and test has not been…
- 02
Procedures for corrective and preventive action have…
- 03
Production processes were not monitored to ensure that a device…
- 04
Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have…
This inspection in context
Amanda S. Zorn
3 documents · 2014–2016
Cites 820.100 (corrective and preventive action) more than any other section. Most of their documents are for sites in Utah.
The firmEdwards Lifesciences, LLC history
All 5 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 820.100
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Edwards Lifesciences, LLC?
FDA listed 13 observations on this Form 483, mostly about production & process controls, cAPA and management controls. The most-cited regulation is 21 CFR 820.100 (corrective and preventive action). The opening words of each observation are shown on this page.
Who inspected Edwards Lifesciences, LLC?
Amanda S. Zorn, James R. Montero, Janet Pulver and Sean T. Creighton are named on this Form 483, for the inspection of Mar 3 – Apr 11, 2014. Each investigator has a profile showing what they cite most.
When was Edwards Lifesciences, LLC inspected by FDA?
The inspection ran Mar 3 – Apr 11, 2014, and the Form 483 is dated April 11, 2014.
How do I get the full Form 483 for Edwards Lifesciences, LLC?
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.