www.fdanews.com/articles/165178-heartware-lands-warning-letter-for-validation-capa-concerns
HeartWare Lands Warning Letter for Validation, CAPA Concerns
June 13, 2014
Coronary device company HeartWare International said Wednesday that it received an FDA warning letter related to the company’s Miami Lakes, Fla., manufacturing facility.
Devices & Diagnostics Letter
Devices & Diagnostics Letter