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How to Meet Compliance and Records Requirements of the US Food and Drug Administration

This article was originally published in RAJ Devices

Executive Summary

Records prove compliance. So why did 271 pharmaceutical and medical technology companies in the past 14 months receive regulatory enforcement notices from the US Food and Drug Administration citing records-related failures such as “failure to maintain accurate, complete, and current records”1 or “failure to retain all required records”2? Did the executives in these companies confuse standard operating procedures with FDA compliance?




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