FIRMS, FDA NEED BETTER COMMUNICATION ON INSPECTION PROCESS, EXPERTS SAY
Devicemakers can help ensure smoother FDA inspections of their facilities by improving their communication with inspectors and making sure their regulatory affairs personnel fully understand the quality system regulation, experts say.
The problem is that the FDA "has the ability to criminally prosecute firms and the responsible individuals" who manufacture and distribute devices the agency deems "misbranded" or "adulterated," consultant Nancy Singer, president of Compliance-Alliance, said. As a result, when an FDA inspector is in a plant, "the knowledge that the investigator could be collecting evidence for regulatory action may get in the way of open communication."
The case of United States v. Utah Medical, which was decided in favor of Utah Medical a year ago, is one example of the problems that can arise from miscommunication between firms and FDA inspectors.
FDA inspectors cited the firm for its processes and procedures, rather than product safety issues. In dismissing the government's case, the federal court ruling stated, "The fact that the road chosen by Utah Medical may be different in degree than thought to be appropriate by a regulator does not mean that it is wrong or in violation of the regulations."
"It seems to me that a recurring problem in this extended and, in some instances, 'nitpicking' case is a failure of the regulator and the regulated to communicate," Senior District Judge Bruce Jenkins wrote.