A North Carolina syringe factory that has been linked to the heparin scandal operated for almost two years without an inspection by the FDA. In a story published by the Associated Press the FDA failed to inspect the company even after complaints were filed about the syringes being dirty or filled with colored particles.

In 2007, before the heparin outbreak, the FDA received more than a dozen reports of problems with the AM2PAT’s syringes. Some reported “orange specks” floating inside the unopened syringes, and others reported “yellow sediment” or “muddy brown” syringes with floating white specks.

The FDA says they first received complaints of particles in the heparin syringes in November 2005. An FDA spokeswoman said the company was inspected in January 2006, but wasn’t checked again until December 2007—22 months later.

While the FDA declined to release its inspection reports from the January 2006 and December 2007 visits to the syringe plant, the reports could be released through a Freedom of Information act request.

This entry was posted on Monday, March 2nd, 2009 at 4:03 pm and is filed under Heparin, Safety. You can follow any responses to this entry through the RSS 2.0 feed. You can leave a response, or trackback from your own site.