Warning: API Maker Did Not Act on Contamination Risk Quickly

Zach System, 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 cross-contamination.

The company discovered the cross-contamination during an investigation of a March 2008 complaint about metallic foreign material found in its pioglitazone HCl diabetes drug, the letter says. Zach 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 recently on the FDA’ website.

The agency is concerned that while the investigation is open, drugmakers may still be manufacturing products with affected lots.
Drug GMP Report