A new complaint filed by the Office of Special counsel indicates inspection officials at the Food and Drug Administration downplayed major concerns regarding safety and hygiene at a Merck factory being used to produce the Johnson & Johnson COVID vaccine.
According to a former safety officer with the FDA, inspectors downgraded the facility from a category that would require immediate corrective action to a category with less urgency after a 2017 inspection, but did so without following the proper procedures and despite some significant public health concerns.
Case background
In 2018, the whistleblower discovered Merck was improperly disposing of biohazard bins that had been used to collect employees’ waste, and that rather than taking bathroom breaks that would have required them to leave the manufacturing area, employees were soiling their uniforms. He accused Merck of purposefully destroying evidence of these health and safety violations.
In early March, Merck agreed to help Johnson & Johnson bottle millions of its vaccine doses, and would begin producing the vaccine itself by the later half of this year.
The FDA reclassified the status of the plant to ensure it would not undergo further scrutiny, according to the whistleblower. If it had instead stayed classified in the more severe category. Merck would have needed to prove it addressed the past FDA concerns, or else face restrictions.
The whistleblower also claimed the FDA’s inspection unit was horribly understaffed in such a way that could compromise compliance efforts.
For more information about the steps you should take if you uncover serious safety risks being covered up by your employer, contact an experienced whistleblower lawyer at Kardell Law Group.
