The FDA is taking its licks in North Carolina today, where a leading newspaper reports the agency ignored reports of contamination at a syringe facility. Not just any facility, but AM2PAT, whose tainted heparin and saline syringes were linked with five deaths before they were pulled from the market.
The Raleigh News & Observer reports that the FDA received "numerous complaints" about sediment and debris in the medicine, beginning as early as 2005. Besides the five patients who died, another 100 were sickened after receiving the IV drugs. The complaints continued in 2007; in one case, "food particles" were reported to be floating in the liquid drug. The bacterial infections surfaced in December 2007 and January 2008.
According to an FDA spokesperson, inspection reports show the plant was visited by FDA inspectors in June 2005, January 2006 and December 2007.
This week, two company officials pleaded guilty for their roles in the contamination; they falsified documents to make it appear that the products had been properly tested for sterility. AM2PAT's president, Dushyant Patel, also faces charges, but he can't be located.
AM2PAT's Raleigh-area plant was in "flagrant violation" of good manufacturing practices, court documents and photographs show. Its so-called "chief microbiologist" was actually a teenager who'd dropped out of high school. Key lab equipment was broken, and the "clean room" was ventilated with a box fan, the N&O reports.