Do FDA’s Procedures make it Easier to Cover-up Negative Audit Findings?
(Thursday, 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 processes and ways manufacturers can prepare to avert negative findings during an audit despite an aggressive auditor. The case in point is where an FDA inspector complained of (1) not being provided adequate resources or time to conduct a reasonable inspection, (2) non-timely sharing of whistleblower complaints regarding the audited site with the FDA inspector, (3) FDA manager downgrading inspection findings despite the inspector’s insistence to the contrary, and (4) FDA’s aggressive suppression of its own investigator for disagreements with his manager. The disagreement became so contentious within the FDA that the FDA inspector filed a written complaint, was fired (or forced to resign) and gave interviews to media, which lead to an independent investigation by the US Office of Special Counsel (OSC). This may sound unreal as it is opposite to what one would expect from FDA’s processes. Why would FDA not agree with one of its own investigators and take punitive action against a manufacturer? The answer seems to be the limitation of FDA’s internal procedures for risk assessment. The following information emerges regarding FDA’s processes. First, the managers at FDA decide the resources needed for an audit not the inspectors. Inspectors can request additional resources, but the managers have the sole discretion to grant or deny those requests. Second, the inspectional findings are reviewed by the FDA managers for concurrence with observed facts and responses submitted by the audited party. In this case, the manufacturers had removed all the violations cited in the whistleblower complaints prior to the FDA inspection so the inspector did not directly observe those violations but concluded that the manufacturers obstructed audit based on discussions with the whistleblower; the FDA manager and legal staff disagreed and concluded that the whistleblower’s compliant could not be corroborated. Third, the FDA supervisors make the final determination regarding the actions taken for the audited site based on the findings at inspection, the past inspection/compliance history, and responses to the FDA 483 received by FDA. The FDA Managers have the discretion to deny an inspector’s request to escalate the findings if they do not agree. FDA managers are required to create a “Reclassification Memo” when they classify a violation to be a different grade than the one recommended by their own inspectors, but these memos are quite cryptic and lack detailed rationale for the reclassification. It is hard to evaluate the specifics cited in this case and we certainly hesitate to generalize this to all FDA audits. Even the OSC concluded that in this case the FDA followed procedures. The OSC did not provide any specific recommendations other than asking the FDA “to closely examine compliance matters like these”. So, basically, if the manufacturers do a good pre-review of their compliance and address all the potential issues, they could avoid negative outcomes even if they have internal whistleblowers telling FDA otherwise. Sounds logical, right!!

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AUTHOR               

 Dr. Mukesh Kumar
​ Founder & CEO, FDAMap

 Email: mkumar@fdamap.com
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