CHARLOTTE, N.C. (Legal Newsline) — The Department of Justice announced Jan. 12 that Baxter Healthcare Corporation (Baxter) will pay $18.158 million after allegations it failed to follow current Good Manufacturing Practices (GMP) while manufacturing sterile drug products in North Carolina.
“Despite notification by an employee of potential contamination concerns, Baxter was poorly focused on instituting sufficient safety standards for their products,” said U.S. Attorney Jill Westmoreland Rose for the Western District of North Carolina (WDNC). “Today’s resolution reflects WDNC’s commitment to hold accountable drug companies that violate manufacturing standards and wrongly profit from those violations.”
Of the settlement, $16 million will go toward monetary penalties and forfeiture through a deferred prosecution agreement and $2.158 million will go to the federal government as a civil settlement for alleged False Claims Act violations.
“FDA’s manufacturing standards are designed to ensure the quality, safety, and efficacy of drugs distributed to American consumers, and FDA expects pharmaceutical companies to correct deficiencies in an expedited manner,” said special agent in charge Justin Green of FDA’s Office of Criminal Investigations' Miami Field Office. “We will remain vigilant in our efforts to protect the U.S. public health from potentially dangerous products.”