FDA downplayed safety risks at Merck plant producing J&J COVID-19 vaccines, whistleblower says

A complaint filed March 31 by the Office of Special Counsel alleges that the FDA minimized safety and hygiene risks at a Merck plant that is being adapted into a manufacturing site for Johnson & Johnson's COVID-19 vaccine.

In the complaint, a former FDA officer alleged the agency downgraded a Merck plant from a category that required immediate corrective action to a less urgent one that doesn't require further scrutiny following a 2017 inspection. The complaint said this move did not align with established FDA procedures and failed to consider the significant public health concerns the inspection found.

The public version of the complaint did not name the whistleblower or the location of the facility, but Arie Menachem, a former FDA safety officer, confirmed to Politico that he made the allegations and that the facility is located in Durham, N.C.

The complaint says the plant's employees were "soiling their uniforms rather than taking bathroom breaks which would have required them to disrobe and leave manufacturing areas." It says that in 2018, Mr. Menachem discovered Merck had improperly disposed of biohazard bins containing uniforms contaminated with employees' excrement and intentionally destroyed the evidence of those violations.

Merck agreed March 2 to manufacture Johnson & Johnson's COVID-19 vaccine. Its Durham site will produce Johnson and Johnson's vaccine and another one of its sites in Pennsylvania will bottle it, according to Politico.

More articles on pharmacy:
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Pfizer, BioNTech to test version of their COVID-19 vaccine that doesn't need ultracold storage
Shipments of J&J COVID-19 vaccines halted as FDA probes error that ruined 15M doses


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