FDA issued a Warning Letter to Edwards Lifesciences, LLC on 5/24/2013 for a previous inspection.
483 Edwards Lifesciences Apr 2014

483 Edwards Lifesciences Apr 2014

Sean Creighton FDA, James Montero FDA, Janet Pulver FDA, Amanda Zorn FDA$119.00 - Available Now

FDA investigators audited the Edwards Lifesciences - Draper, UT, United States facility and issued 13 inspectional observations (via FDA 483) on 11 Apr 2014.

Product details

  • Category: Medical Devices & Rad Health
  • Number of Observations: 13
  • Inspection end: 11 Apr 2014
  • Location: Draper, United States
  • FEI: 1713910
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