FDA: Firm Accused of Sending Contaminated Syringes Had Been Warned in 2005

Two years before syringes from a North Carolina medical device maker were linked to an outbreak of bacterial contamination blamed for at least five deaths and hundreds of illnesses, the Food and Drug Administration warned the company about significant safety violations at the plant, officials said.

The company, AM2PAT Inc., is accused of skipping sterilization testing of its syringes in 2007 and shipping contaminated needles filled with the blood-thinner Heparin and saline solution used to flush intravenous lines. AM2PAT Inc. reportedly sold $7 million worth of the syringes in 2006 and 2007, but infections from the contaminated needles caused a variety of severe injuries, including spinal meningitis and permanent brain damage.

This week, the FDA announced that two former plant workers have been sentenced to more than four years each in federal prison for their parts in the outbreak.

2005 FDA Warning Letter Revealed

The FDA has made public a warning letter the agency sent to the company in August 2005 after nine serious violations were detected during an inspection at its Raleigh factory. Problems at the plant included improper documentation of sterility tests, insufficient efforts to keep the plant sterile, and allowing unqualified employees to work there, including a high school dropout working as a “microbiologist,” according to the FDA.

The company was also faulted for failing to establish written quality control procedures for manufacturing the syringes and other devices, authorities said. In the 2005 letter, the FDA warned that failure to improve conditions at the manufacturing facility “could reasonably be expected to have an adverse effect on product quality.”

Company Vowed to Improve

Following the 2005 warning, AM2PAT officials promised to correct the problems and a follow up inspection in 2006 found no significant problems, according to the FDA. The next inspection of the facility took place in August 2007, when only a minor labeling problem was noted, the agency said. An outbreak of infections connected to AM2PAT syringes was then reported starting in December 2007.

CEO is Missing

U.S. authorities are searching for Dushyant Patel, AM2PAT Inc.’s Chief Officer, who they fear has fled to his native India in an attempt to avoid prosecution in the U.S. Two former company employees have pleaded guilty to fraud and other charges for their parts in the scheme to skip sterilization tests on syringes before shipping them out to customers.

If found and convicted, Patel could face up to 95 years in prison for fraud, false statements, and selling adulterated medical devices, authorities said.

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