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.