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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
The devicemaker also received manufacturing materials from a supplier that was not found on its approved supplier list, an issue the agency said was a recurring observation. Read More
The FDA cited four devicemakers following inspections that revealed problems with process controls, validations, complaint handling and medical devices reports. Read More