An April inspection of Japans Taenaka Kogyo ends in a four-observation Form FDA-483 that cites significant GMP violations.
FDA posts a Form FDA-483 issued to Biocon Biologics at the end of a July inspection at the firms Bengaluru, India manufacturing facility.
FDA publishes a draft guidance on incorporating voluntary patient preference information in medical device total life cycle regulatory decisions.
Federal Register notice: FDA sends to OMB an information collection reinstatement entitled Yale-Mayo Clinic Centers of Excellence in Regulatory Scienc...
Abbott Diabetes Care recalls (Class 1) three lots of its FreeStyle Libre 3 sensors after finding that a small number of them may provide incorrect hig...
FDA says a July Medtronic recall of some McGrath MAC Video Laryngoscopes due to potential battery problems is Class 1.
The Justice Department says Glenmark Pharmaceuticals, a generic drug manufacturer in Mahwah, NJ, will pay $25 million to resolve civil claims involvin...
Breas Medical recalls (Class 1) its Vivo 45 LS ventilators to update the use instructions after internal testing identified the potential for a short-...
