FDA Issues Warning Letters and Import Alert on Ranbaxy Laboratories

Rockville, MD (Sept. 17)-The US Food and Drug Administration has issued two warning letters to Ranbaxy Laboratories (Gurgaon, Haryana, India), one of the largest suppliers of generic drugs imported to the US, expressing what the agency believes is a deviation from US current good manufacturing practice (CGMP) requirements at two of the company’s manufacturing facilities in India: Dewas and Paonta Sahib. Some areas of concern expressed in the warning letters included inadequate batch production and control records, inadequate failure investigations, inadequate written records of cleaning and use of equipment, and inadequate review procedures.

FDA stated in a press release that Ranbaxy has been informed that FDA will deny any new drug applications or abbreviated new drug applications that list either of the two plants as a manufacturer until the company resolves the CGMP deficiencies.

FDA also issued an Import Alert for generic drugs produced by the two plants. The alert allows US officials at the US border to detain any imported active pharmaceutical ingredients (API) or finished drug products that were manufactured at the Ranbaxy facilities. While the alert affects more than 30 generic drugs, FDA stated it believed other drug suppliers could meet market demand and patients should continue to take their medications.

FDA stated in a press release that these actions “are proactive measures that the FDA is taking in order to assure that all drugs that reach the American public are manufactured according to CGMP requirements.” FDA also stated that it did not believe that Ranbaxy has yet shipped any defective products and that products produced at other Ranbaxy’s plants are not affected.

In a press release issued on Sept. 17, 2008, Ranbaxy stated that “the company has just received the warning letters that FDA has issued and has not had the opportunity to review those concerns that FDA has determined are unresolved. Once it has an opportunity to review the issues, the company looks forward to continuing to cooperate with FDA to resolve the remaining issues.”  Ranbaxy also expressed its disappointment by stating that “the company has responded to each concern FDA has raised during the past two years and had thought that progress was being made. We are, however, pleased that FDA’s testing and review led the agency to conclude that there is no reason to question the safety or effectiveness of Ranbaxy’s drugs.”