B. Braun Medical has agreed to resolve criminal liability allegations by paying $4.8 million in penalties and forfeiting an additional $4 million in restitution for selling contaminated pre-filled saline flush syringes in 2007, the Department of Justice announced.
The company also agreed to increase oversight of third party suppliers to prevent future sales of contaminated products.
The syringes carried B. Braun labels but were manufactured by AM2PAT, a third-party manufacturing company in North Carolina.
The use of the contaminated syringes led to an estimated five deaths and multiple infections.
A Series of Missteps
According to documents, B. Braun started working with AM2PAT in 2006, and it was aware of manufacturing problems at the time. The FDA also uncovered GMP deficiencies during a 2007 inspection. Around that time, AM2PAT told B. Braun it would be moving its manufacturing plant, and that it would be changing its sterilization process.
However, before B. Braun’s quality department approved the new plant and sterilization process, AM2PAT began selling syringes manufactured at the new plant, the DOJ said.
B. Braun approved the changes to the manufacturing process even after the company received complaints about the syringes changing color, the DOJ said. Moreover, B. Braun approved AM2PAT’s facility “without overseeing AM2PAT’s operations at its new facility or confirming AM2PAT’s representations that it had properly validated its clean room and equipment after the move.”
Less than two months after moving to the new facility, B. Braun had to recall all of the syringes manufactured at AM2PAT’s facility because the radiation sterilization process caused white particles to develop in the saline.
In connection with the dirty syringes, AM2PAT’s quality control director and plant manager pleaded guilty and were sentenced to 54 months in prison in 2009. The former president fled the country and is on the FDA’s Office of Criminal Investigations’ “Most Wanted” list, DOJ said.