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Failure to establish procedures for quality audits and management reviews landed C-PAP maker Somnowell a May 12 warning letter for numerous quality system violations. Read More
FDA is recommending that device manufacturers redesign heater-cooler devices used in surgeries because cleaning maintenance challenges have been linked to infections and patient deaths. Read More
Failure to set requirements to evaluate suppliers landed Berwickshire Electronic Manufacturing, a UK contract manufacturer, an FDA warning letter. Read More
Not finding the root causes of problems or documenting complaint evaluations landed General Devices, maker of mobile telemedicine systems, a warning letter from the FDA. Read More
FDA is incorporating a risk-based approach for analyzing biocompatibility of medical devices that come into direct or indirect contact with the body. Read More
TYRX, a Medtronic subsidiary and developer of absorbable antibacterial envelopes, received an FDA warning letter for issues with CAPA investigations and change controls. Read More