FDA Warning Letter — Edwards Lifesciences, LLC

Case 87305 — FEI 2015691

The FDA took a Warning Letter action against Edwards Lifesciences, LLC on March 1, 2010 (Irvine, CA). The action was issued by CDRH and concerns devices products. This facility has 5 or more recent FDA inspections on record.

Action Details

Facility
Edwards Lifesciences, LLC
Date
March 1, 2010
Fiscal Year
2010
Product Type
Devices
Center
CDRH
Location
Irvine, CA (United States)