Baxter Healthcare Corp, subsidiary of Baxter International based on Deerfield has agreed to shell out $18 million and pay the federal government over allegations that the company had violated federal drug manufacturing standards . The government alleges that between 2011 and 2012, the company had manufactured sterile intravenous solutions in a North Carolina facility.
It was later found out that the production room were the supposed sterile solutions were manufactured, supposedly had molds in the air filters in the ceiling. Allegedly, a Baxter company employee had informed the company's management about the mold but the company failed to act on this report and continued to manufacture drugs in that particular room.
U.S. Food and Drug Administration had conducted an unannounced inspection and found molds on the filters although no evidence that the IV solutions were contaminated by the mold. Baxter has admitted that they distributed products in interstate commerce that were adulterated. This was a violation of federal law.
Baxter spokeswoman Deborah Spak states that although the production of the lines were not consistent with the company's standards, there was no evidence that the products manufactured during that time period were impacted. Several of the members of the North Carolina facility's management team have been laid off as a result of the occurrence according to Spak.
Spak also said that enhanced training and compliances processes are now being given to employees of the facility. The company has also made organizational changes and improved inspections and environmental monitoring.
Spak went on to say that health care providers and patients rely on their product in critical situations. It is an important responsibility on the part of the company to maintain the highest standards for the company, its products and the process as reported in Chicago Tribune.
Baxter Healthcare Corp will also pay a Marion whistleblower Chris Wall who reported the moldy air filters. Wall is set to receive $430,000. Wall's action had sparked the investigation of the company's practices by the federal government in 2012.
Baxter is the largest employer in McDowell County and employs more than 2,000 people according to N.C. Department of Commerce data from 2015.
The Marion facility manufactures premixed drugs, IV therapies, renal therapies and other sterile solution. The products comprises about 60 percent of all IV solutions in the U.S. market according to an article by Citizen-Times.
