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FDA’s Lax Investigation Leads to Shipment of Contaminated Syringes

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Natalie Fullerton’s parents were thrilled to see their year-old daughter recover from a double-lung transplant. Her father dutifully used fluid-filled syringes to clean a tube that doctors had implanted in her chest to deliver intravenous medication. Despite his fear, bacteria infected the toddler’s blood and she was rushed to the hospital. Four months later, Natalie died in her mother’s arms.

The syringes Mr. Fullerton had been using were part of a contaminated lot made in a factory owned by Lake Zurich businessman Dushyant Patel. That batch and another have since been linked to 4 deaths and 162 illnesses across the country. Inspection reports and other documents show that the U.S. Food and Drug Administration missed several opportunities to prevent the tainted syringes from being used.

Three months before the prefilled syringes were shipped in October 2007, an FDA inspector investigated reports of red, brown, and black particles floating in syringes. She reported that the North Carolina plant managers had a plan to deal with rust, but did not note that the plant had switched to an unreliable sterilization tactic. When the FDA learned a week later that a distributor had recalled 1.3 million syringes, it should have conducted a thorough inspection of the plant, according to its operations manual. An FDA spokeswoman reports that this didn’t happen because the agency is so understaffed that it no longer follows the policy unless the recalled product poses a reasonable probability of serious injuries or death.

Federal prosecutors zeroed in on AM2PAT President Patel. An indictment on fraud, conspiracy, and other charges alleges that his firm produced syringes laced with bacteria and lied about performing sterility tests. Two employees, one a plant manager, were sentenced in February to 4 ½ years in prison for fraud and allowing tainted drugs into the marketplace. Authorities believe that Patel fled to India and are seeking to extradite him.

Patel bought a share of the North Carolina business and took over as president in 2001. Prosecutors allege that the operation was a fraud from the start, and that the firm’s application to make syringes incorporated fake data for a test to establish shelf life of the syringes. Unaware, the FDA gave Patel permission to start production in 2003.

The firm bought empty syringes and filled them with saline or heparin, solutions designed to prevent blood clots from forming in catheters. AM2PAT then sold the syringes to distributors who marketed them to hospitals and pharmacies, earnings nearly $7 million in profits in its last two years. In March 2005, a pharmacist reported finding orange sediment floating in one syringe and spotting an inch-long hair in another. An FDA inspector spent six days in the Raleigh plant three months later, noting nine significant violations, some of which could have an adverse effect on product quality. Shortly after, the FDA sent a warning letter, but it reported in January 2006 that Patel had either fixed or promised to address the major problems. New complaints were lodged in the spring and summer of 2007, including an AM2PAT employee who claimed that management was not adhering to appropriate clean-room temperatures during manufacturing.

The FDA’s Atlanta branch scheduled an inspection for June 26, 2007, but the plant was shuttered when the inspector arrived in Raleigh. By the time an inspector located the new plant, B. Braun Medical had recalled more than 1 million syringes following reports of particles floating in the saline. Six weeks after the inspection, the FDA issued a news release on the B. Braun recall’s finding that the particles were medical-grade silicone, which is capable of causing brain damage or a deadly clot. The FDA now admits that, until reports of injuries mounted, its Philadelphia office did not communicate information about the recall to its Atlanta office.

Toward the end of October 2007, the plant shipped the contaminated heparin-filled syringes. Authorities now link four deaths to the contamination. After the CDC linked the syringes, two investigators and a microbiologist interviewed workers, dug through records, examined equipment, and studied quality control in the factory. Patel had apparently concluded that the white particles that spurred the recall were caused by the failure of a standard sterilization process involving radiation. He adopted “UV light” sterilization, which the FDA says is a non-traditional technique. An employee also told investigators that the company kept two sets of records: one revealing rushed shipments of syringes that hadn’t completed sterilization tests and another fraudulently indicating that the plant was holding syringes on-site for two weeks while chemists conducted sterility tests. Patel responded that someone was sabotaging his records.

Gordon Harnack, a consultant who helps companies prepare for inspections, reviewed more than 120 pages of FDA reports on the AM2PAT plant and concluded that inspectors didn’t look deep enough, even as contamination problems became apparent. Although the syringe case has not received the attention that followed deaths from salmonella-laden peanut paste, consumer advocates say that both breakdowns are the result of a shift from aggressive enforcement to FDA partnership with the industries it is meant to oversee.

In response, FDA Commissioner Margaret Hamburg has pledged to make product safety a top priority. She said that she believes that it is critical for the FDA to take an aggressive approach to inspections and to maintain vigilance in ensuring that manufacturers comply with regulatory, legal, and moral obligation to provide safe products. FDA spokeswoman Siobhan DeLancey had previously defended the agency’s actions, saying that they had inspected the plant multiple times on a relatively low number of complaints and that the agency worked hard to prosecute the plant managers once reports of infections came in. This prosecution came too late for the Fullerton family, however, and many affected individuals have filed lawsuits in Cook County.