The facility located in Toansa is the facility that received the restrictions from the FDA. The company supplies a lot of generic drugs to the US. This is not the first issue with products from the company as in 2012 the facility in Paonta signed a consent decree to ensure compliance with the FDA. This makes for a total of 4 plants in India being banned from the US. Due to past issues the company was pretty much supplying the raw materials to US Ranbaxy and other drug plants as the former problems pretty much took them out of the loop for sending finished products to the US.
The company will need to use a 3rd party to assess the situation and remedy the manufacturing and content solutions. In addition raw materials already at facilities in the US cannot be distributed. The company is still bouncing back from the whistle blower case where Ranbaxy was fined $500 million. The video on the fines settled last year explains the FDA investigation with a long past with Ranbaxy.
The data from Ranbaxy was a dark hole and the company had a pattern of submitting data with errors. There is not yet a list of what drugs will be affected and the FDA states they are immediately looking for any areas to where the a drug shortage could take place. BD
The U.S. Food and Drug Administration today notified Ranbaxy Laboratories, Ltd., that it is prohibited from manufacturing and distributing active pharmaceutical ingredients (APIs) from its facility in Toansa, India, for FDA-regulated drug products. The Toansa facility is now subject to certain terms of a consent decree of permanent injunction entered against Ranbaxy in January 2012.
The decree contains, among other things, provisions to ensure compliance with current good manufacturing practice (CGMP) requirements at Ranbaxy facilities in Paonta Sahib and Dewas, India, as well as provisions to address data integrity issues at those facilities. In September 2013, the FDA added Ranbaxy’s Mohali facility to the CGMP provisions of the decree.
Under the decree, the FDA has issued an order prohibiting Ranbaxy from:
• distributing in the United States drugs manufactured using API from Toansa, including drugs made by Ranbaxy’s Ohm Laboratories facility in New Jersey;
• manufacturing API at its Toansa facility for FDA-regulated drug products;
• exporting API from Toansa to the United States for any purpose; and
• providing API from Toansa to other companies, including other Ranbaxy facilities, making products for American consumers.
“We are taking swift action to prevent substandard quality products from reaching U.S. consumers,” said Carol Bennett, acting director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research. “The FDA is committed to ensuring that the drugs American consumers receive – no matter where they are produced – meet quality standards and are safe and effective.”
The FDA’s inspection of the Toansa facility, which concluded on Jan. 11, 2014, identified significant CGMP violations. These included Toansa staff retesting raw materials, intermediate drug products, and finished API after those items failed analytical testing and specifications, in order to produce acceptable findings, and subsequently not reporting or investigating these failures.
The agency is evaluating potential drug shortage issues that may result from this action. If the FDA determines that a medically necessary drug is in shortage or 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.