Day: April 1, 2021

We often hear the manufacturer’s side of the FDA audit experience but not what happens internally at the FDA. A recently concluded investigation of a disagreement between an FDA inspector and his manager regarding his reports of non-compliance at manufacturing facilities by the Office of the Special Counsel provides a unique insight into FDA’s internal … Read more

Complaints by whistleblowers do not lead to automatic investigations by FDA and could take years for FDA to find credence. Many a times we know about whistleblower complaints to FDA that seemingly do not go anywhere as the alleged violators continue without any FDA investigations or negative consequences. There is no simple answers as to … Read more