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Whistleblower: FDA didn't react to blood, urine and feces in Merck facility

Christian Fernsby |
A whistleblower claims there were violations at a number of pharma companies, including a Merck & Co. in Durham, North Carolina, where staff destroyed evidence of unsanitary practices.

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Topics: FDA    MERCK   

The Office of Special Counsel wrote President Joe Biden to detail the claims.

Special Counsel Henry Kerner told the White House he was "most concerned" about the Merck inspection and agency follow-up. The Merck plant is slated to help produce Johnson & Johnson's COVID-19 vaccine, though that work has not begun yet.

The whistleblower alleged that employees at Merck's plant were moving between cleanrooms and uncontrolled areas without properly ungowning, and that a biohazard bin contained employee uniforms soiled with blood, urine and feces.

Employees were soiling their uniforms rather than taking restroom breaks, the whistleblower claimed, citing a confidential informant, because staffers would have otherwise needed to remove sterile gowning and leave manufacturing areas.

Kerner told the White House that the whistleblower had "substantiated serious misconduct in the Merck Sharp and Dohme facility, which the FDA seems to deny."

You can read the whole letter here.

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