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The FDA last month approved St. Jude Medical’s Allure Quadra Cardiac Resynchronization Therapy Pacemaker (CRT-P), Assurity pacemaker and Endurity pacemaker families of devices. Read More
Abbott Vascular received an FDA Form 483 because its Temecula, Calif., facility did not have a procedure defining storage conditions for certain biological indicators. Read More
Radlink, a Gardena, Calif., devicemaker, was handed a Form 483 for lacking a “clear agreement with suppliers and contractors” on notification before changes to products or services. Read More
The FDA has warned Ultradent, a dental device manufacturer, for significant and repeated quality violations related to CAPAs, packaging, labeling and device design. Read More
Just as Hospira’s Rocky Mount, N.C., production plant was starting to reel itself back from a devastating 2010 FDA inspection, the facility has been handed a fresh warning letter complaining that its corrective and preventive action procedures for medical devices fall short of expectations. Read More
HHS’ health IT coordinator is calling for all electronic health records to incorporate the unique device identifiers of implantable devices by 2015. Read More
DexCom, a San Diego maker of continuous glucose monitors, has been warned over medical device reporting failures and problems with its MDR procedure. Read More
If devicemakers audit their procedures for equipment verification and validation, change control, documenting complaints, including complaints received orally, and CAPA recordkeeping, they will have touched on those parts of the quality system that most often generate findings during an FDA inspection. Read More