News Article
Food and Drug Administration Blocks Imports of Ranbaxy Generics
The Food and Drug Administration on Sept. 16 said it would not allow generic drugs made by Ranbaxy Laboratories Ltd. at two of its Indian manufacturing plants to cross U.S. borders, citing an extensive history of manufacturing violations at those facilities.
According to the FDA, Ranbaxy is one of the largest foreign suppliers of generics to the United States. The "import alert" covers 30 drugs made at Ranbaxy's Dewas and Paonta Sahib manufacturing plants, including acyclovir, cefuroxime axetil, fenofibrate, gabapentin, metformin HCl, ranitidine, and simvastatin. The alert also covers six active pharmaceutical ingredients.
Such a wide-ranging shutdown is not common for violations of "good manufacturing practices." But in a teleconference with reporters, Deborah M. Autor, director at FDA's Center for Drug Evaluation and Research Office of Compliance, said the alert and two warnings letters were issued because of the seriousness of the manufacturing violations and the company's lack of quick and appropriate actions.
FDA testing of drugs produced at the two facilities has turned up nothing of concern yet, said Ms. Autor, adding that the agency "has no evidence that these Ranbaxy products are actually defective."
Consumers were advised not to discontinue any generic medication, even if it was manufactured by Ranbaxy, because of the agency's testing and the lack of adverse event reports relating to the products, said Douglas Throckmorton, deputy director of CDER, in the teleconference.
The FDA first began investigating in 2005 after it received reports of manufacturing violations and allegations of potential fraudulent activity at the Dewas and Paonta Sahib plants, said Ms. Autor. The agency documented significant violations of its good manufacturing practices (GMP) rules during inspections conducted in 2006. FDA and Ranbaxy continued to meet, but the agency did not see significant improvement, Ms. Autor said.
Inspections of both plants early this year once again found significant violations. At the Dewas plant, the FDA cited the potential for cross-contamination from the facility's beta-lactam manufacturing process, inadequate batch production and control records, inadequate failure investigations, and inadequate aseptic (sterile) processing operations.
The agency cited the Paonta Sahib plant for a lack of assurance that responsible individuals were present to determine the firm was following GMP rules, inaccurate written records of the cleaning and use of major equipment, incomplete batch production and control records, and inadequate procedures for the review and approval of production and control records for drug products.
Ranbaxy submitted a response to those inspections, but it was not satisfactory, Ms. Autor said.
The drug ganciclovir, which is manufactured at the facilities, will not be subject to the alert because Ranbaxy is the sole supplier to the United States, said the agency. The FDA is going to work with Ranbaxy to create "additional oversight and controls until the company resolves these manufacturing issues," according to an agency statement.
Ranbaxy has also been under criminal investigation by the U.S. Department of Justice for alleged fraud relating to several of its FDA approvals. Ms. Autor said that the FDA investigation and import alert were not related to that inquiry.
Rep. John Dingell (D-Mich.) and Rep. Bart Stupak (D-Mich.) also have started looking into Ranbaxy's approval history.
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