Friday, March 6, 2009
The FDA, still reeling from a series of regulatory failures and underfunding during the 8 years George Bush was president, is now faced with another unfolding scandal.
Following a nationwide salmonella outbreak linked to peanuts from a manufacturing plant in Georgia that sickened more than 600 people and claimed the lives of nine, news has surfaced that a North Carolina syringe factory, AM2PAT Inc., knowingly distributed tainted syringes and operated for almost two years without a Federal inspection despite a series of complaints that its needles were dirty or filled with suspicious particles.
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.
Shockingly, 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.