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An April inspection of Japans Taenaka Kogyo ends in a four-observation Form FDA-483 that cites significant GMP violations.[ Price : $8.95]
FDA posts a Form FDA-483 issued to Biocon Biologics at the end of a July inspection at the firms Bengaluru, India manufacturing fa...[ Price : $8.95]
FDA publishes a draft guidance on incorporating voluntary patient preference information in medical device total life cycle regula...[ Price : $8.95]
Federal Register notice: FDA sends to OMB an information collection reinstatement entitled Yale-Mayo Clinic Centers of Excellence ...[ Price : $8.95]
Abbott Diabetes Care recalls (Class 1) three lots of its FreeStyle Libre 3 sensors after finding that a small number of them may p...[ Price : $8.95]
FDA says a July Medtronic recall of some McGrath MAC Video Laryngoscopes due to potential battery problems is Class 1.[ Price : $8.95]
The Justice Department says Glenmark Pharmaceuticals, a generic drug manufacturer in Mahwah, NJ, will pay $25 million to resolve c...[ Price : $8.95]
Breas Medical recalls (Class 1) its Vivo 45 LS ventilators to update the use instructions after internal testing identified the po...