Food & Drug Inspection Monitor

摘要

Human Drugs: Boehringer Ingelheim Esparia S.A., Barcelona, Spain; Cambrex Profarmaco Milano, Paullo, Italy; Medical Devices: Seecor, Mesquite, TX; Sterigenics US, Corona, CA; Biologies: Life Gift Organ Donation Center, Houston, TX; Inspection Log; Shelhigh gears up for court fight after refusal to recall heart valve devices: Medical device manufacturer Shelhigh, Union, NJ, has declined FDA's May 2 written request to recall all of its marketed devices because of sterility concerns stemming from an audit last fall by the agency's Center for Devices. Shelhigh, a heart valve manufacturer, is preparing to fight FDA's action in federal court in New Jersey.