FDA didn’t inspect syringe plant despite reports

More excellent results from the "do away with government regulation because business will self-regulate" crowd.

And I notice that this information was made available more than a year later, after the election last year. And it will be forgotten by the next election.

http://www.msnbc.msn.com/id/29369892/

updated 6:17 p.m. ET, Wed., Feb. 25, 2009

RALEIGH, N.C. - A North Carolina syringe factory linked to hundreds of sicknesses and five deaths operated for almost two years without an inspection despite a series of complaints that its needles were dirty or filled with colored particles.

Court documents in the North Carolina case show the U.S. Food and Drug Administration only inspected the AM2PAT Inc. plant in December 2007 after an outbreak of illness was reported by the Centers for Disease Control and Prevention.

Federal investigators contend that the company was so consumed with maximizing profits that it shipped syringes filled with saline and the blood-thinner heparin from a dingy facility without ensuring they were sterile. Authorities are now searching for the Chicago-based company’s CEO Dushyant Patel, who was indicted last week. They believe he fled to his native India.

In 2007, before the outbreak of illness was traced back to the company’s syringes, 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.

22-month gap
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.

DeLancey did not have an immediate explanation for why the facility wasn’t inspected for so long. But inspections at AM2PAT were frequent by FDA standards. A Government Accountability Office report issued last year found the agency was more likely to inspect manufacturers like AM2PAT every five years.

“Typically a firm is inspected within two years,” DeLancey said. “They’d prefer to do them faster, but there’s always that resources issue that we have.”

The FDA declined this week to release its inspection reports detailing its January 2006 and December 2007 visits to the plant in Angier, about 20 miles south of Raleigh. DeLancey said those reports could be released through a Freedom of Information Act request, which is pending.
...
AM2PAT, which also sold products under the name Sierra Pre-Filled, produced syringes of heparin and saline, which are often used on already vulnerable patients during cancer treatments, kidney dialysis and other procedures. Along with five deaths, prosecutors say the tainted product sickened up to 300 people, with some of the illnesses resulting in spinal meningitis and permanent brain damage.
...
Assistant U.S. Attorney Jason Cowley said a person who had the title of “microbiologist” at the company was a teenager who had dropped out of high school. Photographs that prosecutors introduced as evidence also show a “clean room” with a window fan patched with duct tape. Other photos show a rundown facility with paint chipping from the floor and syringes piled high on a table.