The Food and Drug Administration said last month 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 the “import alert” covers 30 drugs made at Ranbaxy's Dewas and Paonta Sahib manufacturing plants, including simvastatin, fenofibrate, gabapentin, metformin HCl, ranitidine, and acyclovir.
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 the 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.
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 the CDER, in the teleconference.
The FDA 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.
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 ?-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.
Ranbaxy has also been under criminal investigation by the U.S. Department of Justice for alleged fraud relating to several of its FDA approvals.