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St. Jude Medical said that it has resolved good manufacturing practice issues that had plagued its Plano, Texas, neuromodulation facility, leading to a 2009 warning letter. Read More
The FDA has warned Winter Park, Fla., devicemaker Iradimed for failing to initiate and validate corrective actions related to its infusion pumps and sets. Read More
With FDA investigators soon to begin scrutinizing UDI compliance, Class III devicemakers should prepare by ensuring that UDI changes in design history files are adequately documented and that the company has a verification process for barcodes in place. Read More
The FDA has warned Vention Medical’s Barreal de Heredia, Costa Rica, facility over environmental controls, equipment upkeep and other quality issues. Read More
The FDA has asked Spacelabs Healthcare, a maker of patient monitoring devices, to get an audit from an outside consultant to address problems with corrective and preventive actions and MDRs. Read More
ProTech Professional Products received an FDA warning letter for problems with its corrective and preventive action and complaint procedures and for failing to notify the FDA of significant device modifications. Read More
Manufacturers of moderate-risk devices with a good record of GMP compliance could see less of government inspectors, under proposed amendments to South Korea’s good manufacturing practice regulation. Read More
R&D Engineering, a maker of kidney transport trays, received an FDA warning letter for failing to secure identification labels on devices, among other quality issues. Read More