The U.S. Food and Drug Administration (FDA) has prohibited imported drug products from a Ranbaxy Laboratories, Inc. facility in India due to violations of good manufacturing practices. Workers at the company’s Toansa plant apparently retested raw materials, intermediate drug products and finished active pharmaceutical ingredients (APIs) until they achieved “acceptable” results. According to a news source, this is the sixth Ranbaxy facility that has failed to use good manufacturing practices.
Under a January 23, 2014, order based on a consent decree of permanent injunction entered against Ranbaxy in January 2012, the facility is barred from producing APIs for any U.S. pharmaceuticals until a third-party, independent expert satisfies FDA that good manufacturing practices have been met. FDA has indicated that it “is evaluating potential drug shortage issues that may result from this action.” If a medically necessary drug is at risk of shortage, “the FDA may modify this order to preserve patient access to drugs manufactured under controls that are sufficient to assure quality, safety and effectiveness.” See FDA News Release and Law360, January 23, 2014.