Tainted Syringes Killed 5 Patients – Need Technology at the FDA to Report Quality Control numbers on batches and lots before shi
Posted Feb 24 2009 10:44pm
AM2PAT CEO Dushyant Patel is reported having gone back to India. This is terrible as the 2 factory whistle blowers pleaded guilty for their p art in shipping the tainted syringes. The factory supposed had failed to follow rules for checking sterility and cut corners which resulted in bacterial infested syringes.
200 to 300 patients were infected, and some resulted in spinal meningitis and permanent brain damages. There may even be more as the syringes were recalled in 2007. We really need those quality control servers set up at the FDA, how much longer before we use some technology, even though this is not 100% fix, it will dramatically improve the processes of having each manufacturer send the quality control figures to a bank of servers so FDA agents can also work smarter. BD
(AP) A North Carolina company is accused of bypassing sterilization tests for medical syringes in a cost-cutting move prosecutors say sickened hundreds of patients and led to five deaths. U.S. Attorney George Holding said Tuesday that federal authorities have launched an international search for the executive charged with rushing shipments of bacteria contaminated syringes from an AM2PAT Inc. plant. Two former plant workers who provided prosecutors details about the plant's operations have pleaded guilty for their roles in shipping tainted syringes. The syringes contained Heparin, a blood thinner, and saline, and were recalled in December 2007 after an outbreak of illnesses. Health inspectors identified bacterial infections in Colorado, Texas, Illinois and Florida