Months before an Angier company shipped deadly bacteria-tainted drugs, the federal Food and Drug Administration received numerous complaints about sediment and debris in the medicine.
The FDA received reports about AM2PAT as early as 2005, but not until December 2007 did the agency issue recall notices to pull the drugs off the market.
Two men pleaded guilty in U.S. District Court this week for their roles in the scheme, which involved falsifying documents to make it appear that proper sterility tests had been conducted. The company’s president, Dushyant Patel, faces 10 charges, but he has not been arrested.