Company Tied to Dirty Syringes Warned about Violations in 2005
It has been revealed that AM2PAT, a North Carolina company that manufactured syringes was warned as early as 2005 by FDA investigators that it had several violations in its quality control system. At that time, the company was in Chicago. This was before its needles were linked to a bacterial infection that caused hundreds of illnesses and killed at least five people. The FDA found nine serious violations where the syringes were made to be used in delivery of heparin and saline to flush IV lines.
Earlier this month, prosecutors won guilty pleas in their criminal case from two former AM2PAT employees, giving each of them 4 ½ years in prison for fraud and allowing tainted drugs into the market place. The company’s owner has been charged, but may be on the run in his native India. He faced 95 years if convicted on charges of fraud, making false statements and “selling adulterated medical devices.”
The violations found by the FDA include insufficient efforts to maintain a sterile environment, poor documentation of sterility tests, and unqualified workers. The 2005 letter sent to the company said failures to control a sterile environment “could reasonably be expected to have an adverse effect on product quality.”
Furthermore, there was no sign the employees had been trained properly. One was seen chewing gum as they worked, and another did no gown properly during testing. Pictures show peeling paint, a window fan patched with duct tape in a “clean room” and syringes piled up on a table. One of the more shocking revelations is that the company microbiologist was actually a teenager who had dropped out of high school.
The company vowed to correct these problems, and the next FDA test did not take place until January 2006. The FDA gave the company a satisfactory rating after this inspection. The next test was not until December 2007. This was after Centers for Disease Control and Prevention reported outbreaks of illnesses tied to the syringes. Some of those sickened came down with spinal meningitis and permanent brain damage.
The FDA seems to have continually been linked with dropping the ball on some of the most egregious product safety issues over the past several years. If it isn’t missing salmonella and other food borne illnesses, it’s defective medical devices. One wonders what news stories involving preventable injury and death have yet to come to light.