Edwards Lifesciences, LLC
Form 483 issued November 20, 2015 · Draper, Utah
- Inspection
- Nov 2 – Nov 20, 2015
- Investigators
- James R. Montero· Thai Duong
- Observations
- 5
- Pages
- 3
- FEI number
- 1713910
In short: On November 20, 2015, FDA issued a Form 483 with 5 observations to Edwards Lifesciences, LLC in Draper, Utah (FEI 1713910) after an inspection that ran Nov 2 – Nov 20, 2015. The investigators were James R. Montero and Thai Duong. Most observations concern records & documents and production & process controls; the most-cited regulation is 21 CFR 820.184 (device history record).
At a glance
Records & documents and production & process controls account for 4 of 5 observations.
Most cited: 21 CFR 820.184 (2×)
What FDA observed
Preview: the opening words of each observation- 01
Products that do not conform to specifications…
- 02
The device history record does not demonstrate that the device was manufactured in accordance with the…
- 03
There is inadequate documentation of monitoring and control methods and data…
- 04
Procedures for device history records have…
This inspection in context
James R. Montero
10 documents · 2014–2025
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 820.184
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Edwards Lifesciences, LLC?
FDA listed 5 observations on this Form 483, mostly about records & documents, production & process controls and cAPA. The most-cited regulation is 21 CFR 820.184 (device history record). The opening words of each observation are shown on this page.
Who inspected Edwards Lifesciences, LLC?
James R. Montero and Thai Duong are named on this Form 483, for the inspection of Nov 2 – Nov 20, 2015. Each investigator has a profile showing what they cite most.
When was Edwards Lifesciences, LLC inspected by FDA?
The inspection ran Nov 2 – Nov 20, 2015, and the Form 483 is dated November 20, 2015.
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.