Special Counsel Finds US FDA’s Dismissal Of Inspection Concerns Unreasonable

Agency biologics investigator questioned site classification downgrades and belated response to Merck & Co. plant informant’s concerns.

agency urged to take complaints seriously

An investigation by the US Food and Drug Administration that failed to substantiate an agency whistleblower’s allegations of improperly downgraded and limited biologics inspections drew harsh words from the US Office of Special Counsel, the independent federal investigative and prosecutorial agency that protects federal employees from reprisal for whistleblowing.

The agency's report regarding the former FDA Team Biologics investigator’s allegations of lax oversight met statutory requirements, but its findings...

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