STAT+: FDA is rebuked by a federal agency for downgrading serious concerns over plant inspections

In a stern letter, the U.S. Office of Special Counsel rebuked the Food and Drug Administration over four instances in which agency officials belatedly downgraded troubling findings at manufacturing plants and also urged the FDA to rethink its approach to oversight of inspections.

The investigating agency cited, in particular, a high-profile episode involving a Merck (MRK)vaccine plant in North Carolina, where a whistleblower tipped off the FDA to numerous sanitary problems. An FDA inspector who subsequently visited the plant maintained the violations were serious enough to warrant action by both the FDA and the drug maker. But his recommendations were minimized by supervisors.

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STAT+: FDA is rebuked by a federal agency for downgrading serious concerns over plant inspections

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