Digitek Maker Warned on Quality Control Issues in 2006

According to a document from the U.S. Department of Health and Human Services (HHS), Actavis Totowa - makers of the recalled heart medication Digitek (digoxin) - were warned by HHS after an FDA inspection that took place in the summer of 2006. The FDA’s warning centered on Actavis Totowa’s quality control processes and procedures and range from minor oversights to negligence. According to an article published in 2007 on Entrepreneur.com: “Numerous instances were observed where manufacturing process deviations occurred and in-process specifications were not met, yet there was no indication that action was taken promptly to investigate or to correct the deviations and the products were approved for release and distribution by the quality control unit, the [FDA] wrote.”