The Food and Drug Administration failed to stop a derelict manufacturing plant from shipping contaminated syringes that led to more than 160 illnesses and at least four deaths, according to an investigation by ProPublica and the Chicago Tribune.

For years, a company called AM2PAT produced and shipped syringes prefilled with saline or blood thinners even though FDA had received past complaints about the manufacturer and had witnesses dangerous practices at one of its facilities. For example:

Three months before the pre-filled syringes were shipped in October 2007, an FDA inspector visited the plant in North Carolina where they were made. She investigated reports of red, brown and black particles in syringes and reported that managers had a plan to deal with rust.

Why didn’t FDA take action? Not surprisingly, the agency’s well-chronicled resource shortfall is at least partly to blame. (The article is accompanied by a compelling chart comparing the decline in FDA employees to product complaints.)

A week later, when the FDA learned a distributor was recalling 1.3 million of the syringes, the agency should have launched a thorough inspection, according to its operations manual. That didn't happen, an FDA spokeswoman now says, because the agency is so understaffed it no longer follows the policy unless the recalled product posed a reasonable probability of serious injuries or deaths.

But 2007 wasn’t even the first time FDA had evidence of problems at the AM2PAT facility:

The plant, located in a former strip mall in Raleigh, initially didn't attract much FDA scrutiny. Then, in March 2005, a pharmacist reported finding "copious" amounts of orange sediment floating in an AM2PAT syringe, FDA records show. He saw an inch-long black hair suspended in another.

An FDA inspector arrived at the plant in June 2005 and spent six days, much of it at [AM2PAT President Dushyant] Patel's side. She watched a worker fill a syringe while chewing gum and saw others inspecting syringes at a conveyor that was moving too fast.

She noted nine "significant" violations, records show, some of which could have "an adverse effect on product quality."

When the CDC linked the contaminated syringes to a batch of illness cases, FDA finally ramped up its oversight, which led to the facility’s closing in January 2008.

Read the article here: “Tainted Syringes Slipped Past FDA’s Watch”

Photo courtesy of ProPublica, used under a Creative Commons license.