Despite Complaints, FDA Did Not Timely Inspect Syringe Plant
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AM2PAT Inc., a North Carolina syringe factory, operated for two years without any type of inspection, despite several complaints that its needles were dirty or filled with colored particles. Court documents in the case show the Food and Drug Administration (FDA) only suspected the plant in 2007 after an outbreak of illness was reported by the Centers for Disease Control and Prevention. Along with five deaths, prosecutors say the tainted syringes have caused three hundred people to become sick, with some of the illnesses resulting in spinal meningitis and permanent brain damage.
Investigators allege the company was so consumed at maximizing profits, it shipped syringes filled with the blood-thinner heparin and saline from a dirty factory without insuring they were sterile. The Assistant U.S. Attorney handling the matter says an employee who had the title of "microbiologist" at the company was a teenager that dropped out of high school. Photographs also show a rundown factory with paint chipping from the floor and syringes piled high on tables. Authorities are now searching for the CEO of AM2PAT, Dushyant Patel, though they believe he fled to his native India.
The FDA received many complaints regarding "orange specks" floating inside the unopened syringes, as well as "yellow sediment" and "muddy brown" syringes filled with floating white specks. The agency began receiving complaints in November 2005, and inspected the plant in January 2006. It was twenty-two months, however, until the plant was checked again. This nearly two-year time gap is considered frequent for FDA inspections; according to a Government Accountability Office, the agency usually inspects plants like these every five years.
AM2PAT, which also sold products under the name Sierra Pre-Filled, produced syringes for saline and heparin, which are often used on vulnerable patients during kidney dialysis, cancer treatments and other procedures. In court documents, investigators allege: AM2PAT bypassed internal checks that were designed to ensure the safety of syringes; testing reports were backdated to make it seem as though the syringes had passed internal inspection prior to shipping; as well as some of the test results, which the company was required by federal rules to keep on file, were also fabricated or manipulated.
If true, this behavior is, indeed, criminal. Moreover, the fact that the FDA apparently does not have the resources to adequately inspect such plants, which concern the public safety, is a shame, not to mention incredibly dangerous. This is a public health threat that should be addressed by the current administration and the FDA.