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Cook Vascular was handed an FDA warning letter for marketing the Cook Evolution RL and the Shortie RL Bi-directional Dilator Sheath Sets without marketing clearance or approval. Read More
Routine quality system surveillance inspections of foreign devicemakers increased by 93 percent in 2012, according to newly released FDA data. Read More
As the July 22 deadline for complying with new EU requirements on hazardous substances approaches, some manufacturers of medical devices and active implantable medical devices are feeling a financial squeeze. Read More
MarCor Purification, a maker of water purification systems for the life sciences, has been warned by the FDA over CAPAs, investigations and complaint handling. Read More
A group of FDA task forces has recommended that the agency expand the amount of information it releases on inspections and enforcement, allowing the public to view a more detailed record of a company’s compliance history. Read More
MarCor Purification, a maker of water purification systems for the life sciences, has been warned by the FDA over CAPAs, investigations and complaint handling. Read More