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Topspins, a specification developer and own-label distributor of IV tubing sets, was warned by the U.S. FDA after making design changes without appropriate validation. Read More
Failure to give the FDA a written report of a correction made to its Point-of-Care Unit, an infusion therapy delivery device, resulted in a Form 483 for CareFusion 303. Read More
Women’s healthcare device manufacturer CooperSurgical received a Form 483 for failure to initiate corrective action for a process failure associated with its Blunt Hurd Cannula-Blunt Tip 10mm with 5mm Reducer. Read More
Failure to adequately establish requirements that must be met by suppliers, contractors and consultants resulted in a Form 483 for Steris following a July 14 inspection. Read More
Devicemakers seeking to register products in South Korea say new regulations requiring them to first obtain a Korean good manufacturing practice certificate could delay product launches. Read More
The China Food and Drug Administration plans to beef up its inspections system for medical devicemakers by adding more investigators and improving the performance of quality testing centers. Read More
Customed, a Puerto Rican maker of convenience packs for surgical procedures, received a U.S. FDA warning letter for unacceptable warehouse conditions and other GMP issues. Read More
The U.S. FDA has chosen a veteran public health officer to spearhead its device postmarket surveillance programs. Gregory Pappas joined the agency in February as associate director for national device surveillance in the Center for Devices and Radiological Health’s Office of Surveillance and Biometrics. Read More
The U.S. FDA will roll out a simplified adverse event reporting form this spring in hopes of getting more consumers to use its MedWatch system, agency officials said Feb. 4. Read More
U.S. industry group AdvaMed is working with regulators around the world to ensure a global approach to unique device identification — to avoid scenarios where different countries’ UDI systems can’t communicate with one another. Read More