More regulatory failure: FDA didn't inspect syringe plant despite complaints
It hasn't been a good year so far in terms of preventing regulatory failures at Southern manufacturing plants. The nation is still reeling from a massive salmonella outbreak linked to peanut products from the Peanut Corporation of America's plant in Blakely, Ga., that has sickened sickened some 666 people and may have contributed to nine deaths. More than 2,000 peanut products have been recalled. The deadly outbreak was fueled by poor oversight by food safety regulators and a slow response by federal agencies, experts say.
This week news surfaced that the North Carolina syringe factory, AM2PAT Inc., which knowingly distributed tainted syringes, operated for almost two years without a federal inspection despite a series of complaints that its needles were dirty or filled with colored particles, reports the Associated Press.
AM2PAT is accused of skipping sterilization testing of its syringes in 2007 and shipping contaminated needles filled with the blood-thinner Heparin and saline solution. Along with five deaths, AM2PAT's contaminated syringes sickened some 300 people, causing a variety of severe injuries, including spinal meningitis and permanent brain damage.
Observers point out that while the Georgia and North Carolina incidents represent very different cases, they each can be traced back to a failed regulatory system -- the fact that the Food & Drug Administration doesn't have the manpower to do the policing it needs to do.
In the case of the North Carolina plant, the FDA was aware of problems as early as 2005, but not until December 2007 did the agency issue recall notices on the tainted syringes, reports the News & Observer. An FDA warning letter, made public Thursday by the agency, cited AM2PAT in August 2005 for nine serious violations at its Raleigh, N.C. manufacturing facility, including poor documentation of sterility tests; insufficient efforts to maintain a sterile environment; and unqualified workers.
In 2007, months before AM2PAT shipped the deadly bacteria-tainted drugs, the FDA received more than a dozen reports of problems with AM2PAT's products. Some reported "orange specks" floating inside the unopened syringes, while others reported "yellow sediment" or "muddy brown" syringes filled with floating white specks, according to the Associated Press.
As the Associated Press reports:
FDA records show the agency first received complaints of particles in AM2PAT syringes in November 2005. FDA spokeswoman Siobhan DeLancey said the company was inspected in January 2006 but then wasn't checked again until the December 2007 inspection: a gap of 22 months.
This week, two former employees of the AM2PAT have been sentenced to more than four years each in federal prison for their parts in the outbreak. Authorities are still seeking the company's owner, who will face a 10-count indictment.
