|FDA ignored debris in syringes
Complaints of filth came in 2005; plant's microbiologist was a teenage dropout
News & Observer | February 25, 2009
RALEIGH -- Months before an Angier company shipped deadly bacteria-tainted drugs, the federal Food and Drug Administration received numerous complaints about sediment and debris in the medicine.
The FDA received reports about AM2PAT as early as 2005, but not until December 2007 did the agency issue recall notices to pull the drugs off 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. At least 100 more people were sickened, often after receiving the medicines during chemotherapy, kidney dialysis and other intravenous procedures.
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.
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.
The U.S. Food and Drug Administration — charged with overseeing more than 10,000 drug-device makers in addition to thousands more pharmaceutical manufacturers, food processing companies and animal-feed plants — received complaints about the company’s saline products the summer before the bacterial infections erupted in December 2007 and January 2008.
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 complaint in 2005 noted food particles inside a heparin syringe.
An FDA spokeswoman. Siobhan DeLancey, said a "non-exhaustive" search of inspection reports indicates the Angier plant was visited six times by FDA inspectors, including May 1999, February 2000, March 2004, June 2005, January 2006 and December 2007. But the company wasn't licensed to do business in North Caroline until 2001, and it's original home was in Raleigh. It didn't get FDA approval to load syringes with heparin until 2003.
Patient advocates said the issues that criminal prosecutors detailed in court documents about the plant were red flags that would have prompted an investigator to shut down the plant.
"If they had done inspections, those people would be alive," said Dr. Ned Feder, a former scientist with the National Institutes of Health who now researches FDA issues at the advocacy group Project On Government Oversight. The plant operators, he said, "were counting on the fact that they were unlikely to be inspected. They were counting on it."
Federal law does not require the FDA to inspect a device plant such as AM2PAT before production starts, said Jeffrey Gibbs, an FDA expert with the Washington law firm of Hyman, Phelps & McNamara, who advises health-care companies.
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. Between 2002 and 2007, FDA inspectors visited only about one-quarter of the 5,616 registered plants per year, the GAO report states.