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Newsletter - April 1, 2021

Do FDA’s Procedures make it Easier to Cover-up Negative Audit Findings?

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...Read More
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FDA’s Internal Processes for Handling Whistleblower Complaints Unmasked

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. Read More

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