Syringe whistleblower warned regulators

Syringe whistleblower warned regulators

Sarah Avery - Staff Writer
Published: Fri, Mar. 20, 2009 10:14PM

An employee told federal regulators about troubling conditions in a North Carolina syringe manufacturing plant months before deadly bacteria-tainted devices were shipped to patients, according to documents released Friday.

The worker’s concerns were not immediately investigated by inspectors with the U.S. Food and Drug Administration, whose handling of the AM2PAT syringe case has raised questions about the regulatory oversight of the 10,000 companies that make drug devices used by millions of Americans.

Documents released Friday by the U.S. Food and Drug Administration in response to a request under the Freedom of Information Act indicate that the plant had significant manufacturing problems as far back as 2005.
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That year, a pharmacist notified the FDA of a one-inch black hair found in the barrel of one of the company’s syringes and another syringe with a “rust colored growth in copious amounts of orange sediment suspended in the saline solution.” The FDA inspected and issued a 2005 warning letter for nine serious breaches of proper manufacturing procedures.

But the FDA did not shut the plant down until 2007, after AM2PAT shipped batches of bacteria-tainted syringes to patients and clinics. More than 100 people were sickened, and at least five deaths were linked to the syringes, which were filled with the blood thinner heparin and used during intravenous procedures such as chemotherapy and kidney dialysis.

Efforts to reach an FDA spokeswoman Friday were unsuccessful.

Last month, two workers were each sentenced to 4.5 years in federal prison for falsifying sterility records. The company’s president, Dushyant Patel, is wanted on 10 charges, but is believed to have fled to his native India. The company is now defunct.

According to the inspection records from the FDA, the AM2PAT plant had numerous problems with quality control that foreshadowed the 2007 contamination. In the 2005 inspection and warning letter, FDA regulators cited the company for employing workers untrained for the jobs they performed, keeping lax documentation of sterility tests, and failing to maintain and monitor a sterile environment.

Plant managers promised to correct violations, but follow-up inspections found additional problems. As late as January 2006, the documents show, many of the problems were still not resolved.

Then in June 2007, shortly after the company moved its production from Ransdell Road in Raleigh to a former motorcycle shop in Angier, an AM2PAT whistleblower e-mailed the FDA about the company’s sterility practices.

Specifically, the worker raised concerns about conditions in the so-called clean room at the Angier facility, which was supposed to be carefully monitored for air quality to keep germs from circulating. She also complained that the company’s management “just ignore the complaints from employees.”

Not long after the whistleblower complained, an FDA official went to the company’s former location in Raleigh to conduct an inspection, but found the plant vacated. Two months later, she arrived at the new site in Angier, which was advertised only by “a note with AM2PAT’s name on it posted on the window.”

During that visit, the FDA inspector noted that the plant had “significant objectionable conditions” with its quality control during a 2005 inspection that resulted in a warning letter, but focused most of her attention on a labeling problem on the syringes that stemmed from a name change.

No action was taken, and plant managers promised to put the required identification on their labels.

In December 2007, after 20 cases of Serratia bacterial infections were traced to the AM2PAT syringes, inspectors returned to the plant and it was shut down. Batches of the syringes were recalled, but not before hundreds grew sick. Many people had serious complications, requiring lengthy hospital stays.

Among the problems found in the plant were serious violations in the clean room, just as the whistleblower had warned.

Photographs taken during the government’s criminal investigation show a clean room that features a window fan held together with duct tape. The inspection report notes that there were actually three room fans, all covered in dust, and that a worker was using a “tool resembling a tent stake” to unjam syringe caps coming down a chute.

“The tool (in gloved hand) was observed to repeatedly touch a step stool,” according to the inspector’s observations in the clean room. “The step-stool was observed to have black substance in the tread grooves.”

http://www.newsobserver.com/news/story/1452010.html