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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
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