FDA bans Indian drugs from entering US

“The FDA is committed to using the full extent of its enforcement authority to ensure that drugs made for the U.S. market meet federally mandated quality standards,” Howard Sklamberg, the director of FDA’s drug compliance office, said in a statement. “We want American consumers to be confident that the drugs they are taking are of the highest quality, and the FDA will continue to work to prevent potentially unsafe products from entering the country.”

According to the agency, inspections in September and December of 2012 found multiple violations of current good manufacturing practices at the facility, including failures to inspect problems and maintain manufacturing quality.

Ranbaxy will be prevented from shipping drugs from the plant to the U.S. until it complies with the FDA’s standards.

After news of the import prohibition, the Indian company’s stock fell by 30 percent.

The FDA said that the action would not disrupt the American pharmaceutical market or lead to a shortage.

Monday’s announcement was not the first time the generic drug manufacturer has run afoul of U.S. regulators.

In May, the company pleaded guilty to felony charges and agreed to pay $500 million to the Justice Department for making false statements to the FDA and producing drugs in another Indian facility that did not meet the agency’s standards.