Becton, Dickinson & Co. failed to adequately monitor municipal tap water used during its manufacturing processes, which may have contributed to an infection outbreak and syringe recall issued earlier this year.
The FDA recently released a warning letter sent to BD Medical systems, over problems at its Franklin, Wisconsin facility, where recalled BD PosiFlush heparin syringes and BD pre-filled normal saline syringes were manufactured, but they were linked to dozens of serious bloodstream infections nationwide.
The letter indicates that BD failed to control environmental conditions in the manufacturing plant, specifically citing its unmonitored use of municipal tap water.
“The municipal tap water has been found to be a potential source of microbial contamination through FDA sampling,” the warning letter states. “Your firm does not routinely monitor the municipal tap water for microbial load to ensure dilutions are effective for cleaning and sanitation.”
The FDA investigators found several microbial contaminants in water samples and on surfaces in contact with water.
The letter also indicates that the company failed to prevent contamination of equipment because it lacked adequate cleaning procedures for cleanrooms and laminar flow hoods where aseptic filling of saline and heparin syringes took place.
Investigators found an number of other problems at the BD syringe manufacturing plant, including issues with the cleanrooms and laminar flow hoods, which were detailed in the letter. The agency called for BD to notify the agency in writing of t he specific steps it would take to address the problems. The FDA indicated it has already received some responses that would require a follow-up inspection.
The initial inspection stems from a BD PosiFlush heparin syringe and BD pre-filled normal saline syringe recall issued in April 2018. The recalled syringes were linked to at least 14 serious Serratia marcenscens bacterium bloodstream infections among children in four different states.
The illnesses occurred in Tennessee, Colorado, Minnesota and Ohio among seriously ill children who were given the drugs through intravenous injections through a catheter central line, according to the U.S. Centers for Disease Control and Prevention (CDC). No deaths have been linked to the infections, and the CDC said in May that the illnesses appeared to be winding down.
Heparin, derived mainly from pig intestines, has been linked in past years to serious contamination events. FDA investigations found that heparin sold throughout the United States during late 2007 and early 2008 contained a replacement ingredient known as oversulfated chondroitnin sulfate, which should not be in the drug. The contaminated heparin ingredients were produced at a plant in China. The substitute chemical is substantially cheaper than heparin and was linked to numerous allergic reactions and a number of lawsuits.