OriGen Biomedical recalls two lots of its Reinforced Dual Lumen catheter due to a separation risk involving the clear extension tube from the hub conn...
Federal Register notice: FDA classifies zinc transporter 8 autoantibody immunological test systems into Class 2 (special controls).
FDA warns Indias Vital Laboratories Pvt. about CGMP violations at its API facility in Gujarat.
FDA commissioner Scott Gottlieb and CDER associate director Leah Christi describe agency efforts to educate prescribers about biosimilars.
FDA warns ELITech Group about QS and MDR violations at its manufacturing facility in The Netherlands.
Federal Register notice: FDA classifies the mass spectrometer system for clinical use for identifying microorganisms into Class II (special controls).
FDA warns Germanys DRG Instruments about QS and MDR violations in its manufacturing of several ELISA devices.
Federal Register notice: FDA classifies as Class 2 devices that detect and measure non-microbial analytes in human clinical specimens to aid in assess...