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Florida-based Biolife drew a Form 483 with four observations following a June 2017 FDA inspection. The investigator flagged the Sarasota facility’s inadequate design change documentation and medical device reporting procedures. Read More
A federal judge ruled St. Jude may not dismiss a patient’s allegations over manufacturing-defects and negligence related to the company’s implantable cardiac defibrillator in a case filed with the U.S. District Court for the Northern District of California. Read More