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The firm’s investigation report failed to “include comments from the doctor or medical professional that the incident was not a reportable event,” the agency said. Read More
The FDA cited four devicemakers for problems with their complaint procedures, change controls and quality oversight, among other deficiencies. Read More
The FDA rapped five devicemakers for a variety of violations including complaint handling, validations and failure to establish procedures for process changes. Read More
The FDA issued a June 20 warning letter to Clinicon for quality system lapses related to its SureProble Class II sterile probe following an April 3-4 inspection of the firm’s Oceanside, California facility. Read More
The agency said that the CAPA was launched because “there is a compliance risk due to the fact that internal related procedures...are either nonexistent, are missing required steps in the process, or are not being followed.” Read More
The lab manager told the investigator the firm had no procedure requiring the evaluation of all device complaints in order to figure out if the related event should be reported to the FDA. Read More