In its neverending fight against both poor manufacturing practices and the manufacture and marketing of unapproved drugs, FDA has filed a Consent Decree and expects courts to prohibit Activis’ Totowa, New Jersey facility from further production.
Actavis Totowa—a subsidiary of Iceland-based generics maker Actavis, Inc.—manufactures, packages, and distributes drugs from two sites in Totowa and one in Little Falls, N.J. FDA inspected Totowa's Riverview Drive facility early in 2008 and found that the company had significant cGMP violations and continued to manufacture unapproved drugs.
FDA has issued 483s to the facility based upon past inspections that revealed the company’s failure to investigate serious adverse event reports about some of its products, as well as a host of cGMP improprieties at the facilities including shoddy Quality Control and even one instance of, yes, duct tape being used to keep powder from leaking during production. In the summer of 2008, FDA forced the company to initiate a “voluntary” recall of all its products, from oxycodone to prenatal vitamins, as a precautionary action since the conditions under which the products were manufactured could not be verified as safe. As part of the Consent Decree, Activis must destroy any remaining recalled drugs still in its possession.
"The FDA will not allow manufacturers to put the public's health at risk," says Janet Woodcock, M.D., director of FDA’s Center for Drug Evaluation and Research. "These unapproved new drugs have not undergone FDA review for safety and efficacy and may pose potential health risks."
The Decree also subjects the defendants, Activis, to pay $15,000 per day should they fail to comply with the provisions. The FDA will carefully monitor the provisions of this injunction to ensure compliance, says Michael Chappell, FDA acting associate commissioner in the Office of Regulatory Affairs. "Companies should know that FDA will investigate and take action against other marketers of unapproved drugs."
--PWT
