Federal regulators warned a North Carolina syringe manufacturer of "significant violations" in its quality control system two years before its needles triggered an outbreak of illness that prosecutors say led to at least five deaths.
A U.S. Food and Drug Administration warning letter made public Thursday cited AM2PAT Inc. in August 2005 on nine serious violations at its Raleigh facility.
Investigators noted poor documentation of sterility tests, insufficient efforts to maintain a sterile environment and workers who were not qualified.
Prosecutors say 200 to 300 people got sick with a bacterial infection from syringes used in late 2007.
Prosecutors won guilty pleas this month from two former AM2PAT employees and began an international search for former CEO Dushyant