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FDA didn’t inspect syringe plant despite reports

/ Source: The Associated Press

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.

“Any time you get to a point where there’s a contamination of a syringe you can see with the naked eye, you close down the business if you care about the public health,” Zuckerman said. “You have to assume that this is the tip of the iceberg. If 15 people reported it, it happened a lot more than that.”

‘Microbiologist’ was a teen

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.

“FDA can complain about resources, but if you’re going to triage your resources, I think contaminated syringes would be pretty high on the list (to investigate),” Zuckerman said.

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.

“The pictures speak for themselves in regard to the type of environment that these syringes were being manufactured,” Cowley said.

In court documents, investigators contend: the company bypassed internal checks designed to ensure the safety of syringes; testing reports were backdated to make it appear as if the syringes had passed internal inspection before shipping; and some of the test results, which the company was required by federal rules to keep on file, were also manipulated or fabricated.

Plant manager Aniruddha Patel, 43, of Carpentersville, Ill., and quality control director Ravindra Kumar Sharma, 54, of Richmond, Va., each were sentenced Monday in U.S. District Court in Raleigh to 4 1/2 years in prison for fraud and allowing tainted drugs into the marketplace.

Prosecutors do not know if Patel still has an attorney. He faces up to 95 years in prison if convicted.