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N.C. syringe plant's inspection history sketchy

RALEIGH, N.C. — A company in Angier, N.C., that shipped bacteria-tainted syringes operated under lax federal oversight, despite complaints about its product months before it pulled batches from the market.

AM2PAT, which is now the subject of a criminal investigation, sold tainted syringes of heparin and saline that have been linked to five deaths. Hundreds more were sickened, some resulting in spinal meningitis and permanent brain damage.

Two men pleaded guilty in U.S. District Court this week for their roles in the scheme, which involved falsifying documents to make it appear that proper sterility tests had been conducted. The company's president, Dushyant Patel, faces 10 charges, but he has not been arrested. Authorities believe he fled to his native India and have turned to Interpol for aid in catching up to him.

Conditions at the plant, detailed in court documents and photographs, depict a facility in flagrant violation of proper manufacturing processes. Prosecutor Jason Cowley said the company's "chief microbiologist" was a teenager who dropped out of high school. A key piece of laboratory equipment designed to catch evidence of contamination was broken, and another gauge was out of commission for a year. The so-called clean room, where air is carefully controlled to reduce the spread of germs, was ventilated with an ordinary room fan.

Reports detailing the testing were backdated to appear they passed procedure before shipping, and some test results were manipulated or fabricated to deceive inspectors from the U.S. Food and Drug Administration, prosecutors said.

Patel's company sold nearly $7 million worth of heparin, a blood thinner, and saline syringes in 2006-07. The syringes were recalled in December 2007 after an outbreak of illnesses. Health inspectors identified bacterial infections in Florida, Colorado, Texas and Illinois and traced the contamination to AM2PAT.

The U.S. Food and Drug Administration received numerous complaints about the company's heparin products months before December 2007.

Starting in June 2007, doctors and clinics began reporting to the FDA orange specks floating in the syringes. Other complaints noted "wispy debris" or "yellow-orange sediment" that caused the normally clear product to be tan, orange, "muddy" and "dingy brown" in color. A report in 2005 noted food particles inside a heparin syringe.

It's unknown when or whether the FDA inspected the plant. Efforts to get site inspection reports from the agency were unsuccessful.

Although they are supposed to be inspected every two years, plants such as AM2PAT have instead gotten site visits about once every five years, according to a report from the Government Accountability Office.

"The system depends on companies complying with the law," said Jeffrey Gibbs, an FDA expert with the Washington law firm of Hyman, Phelps & McNamara, who advises health care companies. "If they don't comply, the FDA is not there double-checking all the time. They can't. They don't have the resources."

Information from the Associated Press was used in this report.

N.C. syringe plant's inspection history sketchy 02/24/09 [Last modified: Tuesday, February 24, 2009 11:03pm]
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