Medical - - Jan 14,2017
US-based Baxter Healthcare Corp. has agreed on paying more than $18 million to avoid its criminal and civil liability over claims of violating federal drug manufacturing standards.
The Justice Department said in a statement that the resolution includes a deferred prosecution agreement and penalties and forfeiture amounting to $16 million and a civil settlement under the False Claims Act with the federal government totaling approx. $2.158 million.
The US government had charged that managers at Baxter Healthcare Corp's North Cove plant in Marion, North Carolina, ignored a warning from their own employee that a mold was found in air filters in the ceiling of the room where sterile intravenous solutions were made, according to the statement.
The solutions were required to be made in a clean environment with high-efficiency particulate absorption filters fitted in the ceiling. Due to the mold in the filter, Baxter was accused of shipping large volumes of adulterated sterile intravenous solutions.
The employee had reported the incident in July 2011 but manufacturing continued through November 2012 without the filter being changed. The Food and Drug Administration (FDA) found several species of the mold after it launched a surprise inspection at the plant.
A spokesperson from Baxter said that the production of the lines was not consistent with the company’s standards. He added that Baxter has taken a number of actions to address these issues, including terminating a number of members of the facility’s management team and improving the training and compliance processes for employees throughout the company.
Christopher Wall, the Baxter employee who initially reported the defective filter in a whistle-blower suit, will receive $431,535.99 from the civil settlement. The settlement is now subject to final approval from the federal court.
In 2014, Baxter also recalled some of its dialysis products due to the mold issue.