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Zimmer Biomet had hinted at a warning letter in an SEC filing last month but revealed little details about the exact nature of the deficiencies uncovered at the firm’s facility in Montreal, Canada. Read More
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
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