Parker, Waichman, Alonso LLP

Home » Articles

Tainted Syringe Maker Had History of Violations

Feb 26, 2009 | Parker Waichman Alonso LLP

The company that distributed tainted pre-filled syringes linked to five deaths received a warning letter in August 2005 from the Food & Drug Administration (FDA) regarding atrocious conditions at its Raleigh, North Carolina manufacturing facility.  According to an Associated Press report, that FDA warning letter discussed nine serious violations found at the AM2PAT plant in Raleigh.  

Federal prosecutors have charged that AM2PAT knowingly shipped untested syringes that sickened hundreds and killed five people.  Many of those using the syringes were undergoing chemotherapy treatments which would have compromised their immune systems. In December 2007 and January 2008, Sierra Pre-filled and B. Braun syringes were recalled by AM2PAT because of the contamination issues.

The company's Angier, North Carolina facility was shut down because the problems.  As we reported yesterday, the plant's manager and quality control director  were each sentenced to 4 1/2 years in prison for fraud and allowing tainted drugs into the marketplace.  Both had pled guilty and had agreed to provide information about plant owner Dushyant Patel.  Patel, who may have fled to his home in India, was indicted last week on 10 charges that include fraud and selling adulterated medical device. Interpol is reportedly assisting in the international search for Patel.

According to the Associated Press, the problems cited by the 2005 FDA warning letter included poor documentation of sterility tests; insufficient efforts to maintain a sterile environment; and unqualified workers at its facility in Raleigh, North Carolina.  AM2PAT promised to fix those problems, and the FDA was apparently satisfied that it had done so when it inspected the facility again in 2006. Sometime after that, AM2PAT moved production from Raleigh to Angier, North Carolina, some 20 miles away.

According to the Associated Press, the FDA inspected the Angier plant in August 2007, and said it only found a problem with labeling.  But that was the same month it started receiving complaints that debris had been found in "muddy brown" AM2PAT syringes.  Despite these reports, the FDA did not go back to the plant until the Centers for Disease Control traced infections to the tainted AM2PAT syringes.