Records: Whistleblower at syringe plant warned FDA
Records of the U.S. Food and Drug Administration (FDA) show that a whistleblower's June 2007 warning of unsanitary conditions at an AM2PAT North Carolina syringe plant went unheeded for months. Medical supplies from the plant were implicated in the deaths of five people and the sickening of hundreds of others.
syringe, whistleblower, public health, inspection
An August 2007 inspection failed to investigate the whistleblower's allegations. Within the next few months, the Centers for Disease Control (CDC) reported that AM2PAT syringes were connected to an outbreak of illness; in December 2007, inspectors found extensive problems which the FDA described as making it "impossible" for AM2PAT products to be sufficiently sterile.
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