API Maker Warned for Failing to Act on Contamination

A French active pharmaceutical ingredient (API) maker received a warning letter for failing to take appropriate action on API lots shipped to the U.S. that may be affected by a cross-contamination problem. Although Zach System, based in Avrille Cedex, France, discovered the cross-contamination in March 2008, it did not notify customers until after a June FDA inspection, and its investigation has not defined the extent of the contamination, according to the Oct. 23 letter posted last week to the FDA website.
Drug Industry Daily