St. Jude Medical cleared by FDA
- St. Jude Medical, a medical device manufacturer, was targeted for additional oversight at its Sylmar, CA manufacturing sight in January 2013.
- FDA’s concerns mainly focused on inadequate monitoring and control of manufacturing processes related to Durata and Riata ST Optim high voltage implantable cardiac leads.
- The issues cited by FDA last year have been resolved, but FDA is demanding sustained compliance and has warned of the possibility of future regulatory action.
It’s been a busy 18 months for St. Jude since the company received a warning letter from FDA in January 2013. In addition to taking the corrective actions that led to resolution of FDA’s concerns about its manufacturing processes for some of its implantable cardiac leads, St. Jude Medical also purchased CardioMEMs, a privately held company, in June. The CardioMEMs HF System is the first FDA-approved heart failure monitoring device that has been proven to significantly reduce hospital admissions.
- pharmafile.com St. Jude Medical cleared by FDA