Indian drug maker Ranbaxy Laboratories recently resumed supplying its cholesterol lowering drugs to the U.S. market. The company was shut down by the FDA in January after glass particles were found in some lots of its drugs.
Last January, the FDA and the Department of Justice filed a consent decree of permanent injunction against the company so as to bar it from operating in the U.S. until it fixes its manufacturing issues.
"Because this company continued to violate current good manufacturing practice regulations and falsify information on drug applications, the FDA took these actions in an effort to protect consumers," said Dara Corrigan, FDA associate commissioner for regulatory affairs. "The FDA continues to be committed to protecting consumers from potentially unsafe products that may be offered on the market."
Atorvastatin is a widely used cholesterol drug in the U.S. The glass particles were similar to the size of grain of sand.
Source: The Hindu Business Line, "Ranbaxy resumes supply of Atorvastatin tablets in US," April 24, 2013; U.S. Food and Drug Administration, "Department of Justice files consent decree of permanent injunction against Ranbaxy", January 25, 2012