FDA Warning Letter — SynCardia Systems LLC

Case 537226 — FEI 3003761017

The FDA took a Warning Letter action against SynCardia Systems LLC on April 3, 2018 (Tucson, AZ). The action was issued by CDRH and concerns devices products. This facility has 5 or more recent FDA inspections on record.

Action Details

Facility
SynCardia Systems LLC
Date
April 3, 2018
Fiscal Year
2018
Product Type
Devices
Center
CDRH
Location
Tucson, AZ (United States)