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Devicemakers in the EU need to make sure they have at least two or three employees who are prepared to handle an audit, as notified bodies begin conducting the unannounced audits required by the European Commission. Read More
Traditional methods for training new employees may be failing devicemakers, as most Form 483 observations can be traced back to training deficiencies, several experts say. Read More
St. Jude Medical said Tuesday 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 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
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
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
Med-Mizer, a maker of electric, adjustable and bariatric hospital beds, received an FDA warning letter for failing to submit a timely MDR following a patient death. Read More
CareFusion received an FDA warning letter for failing to analyze debris and particulate matter on its shunts and inside peritoneal catheters and tubing. Read More