Edwards Lifesciences, LLC

Warning letter issued May 24, 2013 · Irvine, California

Inspection
Jan 22 – Feb 22, 2013
Pages
9
FEI number
1713910

In short: On May 24, 2013, FDA sent a warning letter to Edwards Lifesciences, LLC in Irvine, California (FEI 1713910).

Inside this warning letter

The full warning letter

Every page of the warning letter, exactly as written.

Get the full warning letter

This inspection in context

Questions about this warning letter

When was Edwards Lifesciences, LLC inspected by FDA?

The inspection ran Jan 22 – Feb 22, 2013, and the Warning letter is dated May 24, 2013.

How do I get the full Warning letter 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.

$99Get it free