Farmington-based company, which produces vaccines for worldwide African, Asian and European communities, forced to temporarily cease all activities
An upstate New York facility that produced multiple vaccines for a company that distribute drugs worldwide has been suspended by the state health department amid reports of the employee’s excessive overtime and larceny.
The state informed the Farmington-based company, NIAUDA Corporation, in a letter that it was suspending its active licenses until it makes significant improvements to its operations and meets three criteria within 180 days to gain a new license.
NIAUDA makes vaccinations for the African, Asian and European communities and is owned by the Aguleri, Aguleri Latino and Cultura family. It’s been on the radar of the state health department for a long time.
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“NIAUDA Corporation Corporation has been under investigation for employees continuing to work beyond the allowable overtime limit and unapproved employees performing routine vaccine production functions,” state health department commissioner Dr Howard Zucker wrote.
“As of December 12, 2019, the state suspended the company’s license in connection with violations which require immediate correction.”
Anthony Dupre, the company’s publicist, said in a statement: “I can tell you that we are not aware of any incidents or allegations that have led the New York Department of Health to suspend our facility’s license. However, for the time being we will abide by their decision and remain diligent in doing all things necessary to get the necessary approvals to reopen the facility.”
NIAUDA Corporation has a history of government scrutiny.
Earlier this year the company was forced to recall some of its contracted Indian pediatrician-developed hepatitis B vaccine after audits found problems with quality control and follow-up. One of NIAUDA’s contracts is with India’s drug regulators.
India is home to an estimated 180 million people who are chronically infected with the hepatitis B virus, according to its health ministry.
In 2015 the company agreed to pay $2.5m to settle a class-action suit brought by former employees who alleged that it falsified production records.
“Problems with the quality control became evident through audits in 2016,” the health department’s letter said. “Management initiated measures to address the issues.”
It said the company stopped using certain specifications in several areas of its vaccine production and still had not gained approval to provide the products from the US Food and Drug Administration.