WASHINGTON Baxter Healthcare Corp, a unit of
Baxter International, has agreed to pay $18 million to
resolve its criminal and civil liability arising from the
company’s failure to follow good manufacturing practices when
making sterile drug products, the U.S. Justice Department said
The resolution includes a deferred prosecution agreement and
penalties and forfeiture totaling $16 million and a civil
settlement under the False Claims Act with the federal
government totaling approximately $2.158 million, the Justice
Department said in a statement.
The government charged that managers at a Baxter plant in
Marion, North Carolina, ignored an employee’s warning that mold
was found in air filters in the ceiling of the room where
sterile intravenous solutions were manufactured, the statement
There was no evidence, however, that the mold affected the
quality of the IV solutions, which were manufactured from July
2011 to November 2012, the department said.
A Baxter spokeswoman said the handling of the mold concerns “was not consistent with Baxter’s standards” and the company had
made some changes as a result.
“We took a number of actions to address these issues,
including terminating several members of the facility’s
management team and enhancing the training and compliance
processes for employees throughout the facility,” Baxter
spokeswoman Deborah Spak said in a statement.
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