FDA Warning Letter — Heartware, Inc.
The FDA took a Warning Letter action against Heartware, Inc. on June 2, 2014 (Miami Lakes, FL). The action was issued by CDRH and concerns devices products. This facility has 5 or more recent FDA inspections on record.
Action Details
- Facility
- Heartware, Inc.
- Date
- June 2, 2014
- Fiscal Year
- 2014
- Product Type
- Devices
- Center
- CDRH
- Location
- Miami Lakes, FL (United States)