The U.S. Food and Drug Administration (FDA) has banned the importing of drugs from a Ranbaxy Laboratories Inc. plant in India after investigators uncovered rampant violations of U.S.-promulgated manufacturing standards. This is not the first problem of this sort for India’s foremost generic pharmaceutical company. The FDA authorized U.S. customs officials to seize “any and all products” that originated from Ranbaxy’s manufacturing plant in Mohali, India, after determining the plant was not in compliance with a 2012 agreement holding the company to tough standards for manufacturing practices meant to ensure drug safety.
The agreement originally covered four Ranbaxy facilities. But the FDA has extended it to cover the Mohali plant after inspectors identified “significant violations” of FDA-prescribed protocols there in September and December of 2012. Ranbaxy is now prohibited from shipping FDA-regulated products from the Mohali plant to the U.S. Imports will remain frozen until the drugmaker satisfies agency concerns. Howard Sklamberg, director of compliance in the FDA’s Center for Drug Evaluation and Research, made it very clear that his agency was dead serious, stating:
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. 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.
The FDA will require Ranbaxy to hire an independent expert to inspect the facility and certify that new protocols will ensure “continuous compliance” with the agency’s standards. Ranbaxy says it will review the details and will continue to fully cooperate with the government. Incidentally, this import ban is just the latest run-in with U.S. regulators for Ranbaxy. The company entered into a consent decree with the FDA in 2012 when inspectors uncovered a number of problems with drug manufacturing practices at its Paonta Sahib, Batamandi and Dewas plants in India and at a plant in Gloversville, N.Y., owned by its U.S. division. The FDA found that Ranbaxy:
Ranbaxy also agreed to a landmark settlement in May in which it paid $350 million to resolve a whistleblower’s False Claims Act suit over its sales of allegedly adulterated drugs to several government health care programs. The company also paid an additional $150 million as criminal penalties for related felony charges. The tainted drugs were produced in 2005 and 2006, according to prosecutors involved in the case.
The Paonta Sahib and Dewas facilities had been on an FDA import alert since 2008, when the agency blocked more than 30 drugs manufactured at those two plants from entering the U.S., including generic versions of allergy medication Claritin, cholesterol-lowering drug Zocor and heartburn treatment Zantac. The FDA’s latest inspections of the Mohali plant revealed violations of the 2012 agreement including “failure to adequately investigate manufacturing problems and failure to establish adequate procedures to ensure manufacturing quality.” According to a Form 483, detailing violations from the September inspection, FDA officials found that the company did not properly investigate the source of unexplained discrepancies in drug components “whether or not the batch has been already distributed.”
In their report, the FDA inspectors said that Ranbaxy also lacked written protocols to ensure that its mechanical equipment and airborne exhaust systems were properly maintained. Importantly, the inspectors said Ranbaxy had no procedure designed to ensure that its drugs have the “identity, strength, quality and purity they purport or are represented to possess.” Washing and toilet facilities at the plant also lacked hot and cold water, and employees were sometimes unable to wash their hands after using restrooms, according to the report.
The Mohali facility was also the source of generic versions of cholesterol treatment Lipitor that Ranbaxy was required to recall in November due to concerns that the pills might contain tiny glass fragments. Clearly, this company has health and safety problems of an extremely serious nature. The FDA must do whatever it takes to protect the American people from companies such as this one.
Sources: Andrew Scurria and Law360.com
Contact us today for a free legal consultation with an experienced attorney.
Fields marked *may be required for submission.
If you would like to subscribe to the Jere Beasley Report digital edition, simply visit our Subscriptions page and provide the necessary information or call us at 800-898-2034.
Attorney Advertising - Prior results do not guarantee a similar outcome.