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FDA issues warning letters to Ranbanxy

Pharma Compliance Alert, September 24, 2008

Two of generic drug manufacturer Ranbaxy’s plants allegedly violated U.S. current Good Manufacturing Practices (cGMP), prompting the FDA to issue two warning letters and an import advisory, according to an agency release.

One warning letter addressed problems at Ranbaxy’s Dewas, India, facility found during an FDA inspection in early 2008. During that inspection, FDA investigators documented cGMP deviations in manufacturing of sterile and non-sterile finished products and violations related to the manufacture and control of active pharmaceutical ingredients. The FDA’s concerns included aspects of the firm’s quality control program.

The second warning letter addressed the Paonta Sahib, India, facility following an inspection at its Batamandi unit, also in early 2008. The inspection documented various cGMP deficiencies, including:

• The lack of assurance responsible individuals were present to determine the firm was taking necessary steps under cGMP
• Inaccurate written records of the cleaning and use of major equipment
• Incomplete batch production and control records
• Inadequate procedures for the review and approval of production and control records for drug products

The import alert covers various dosage forms and amounts for more than 30 different generic drugs. Under an Import Alert, U.S. officials may detain active pharmaceutical ingredients and sterile and non-sterile finished drug products manufactured at these Ranbaxy facilities.

In a statement, Ranbaxy said it addressed each concern the FDA raised over the past two years. The company said it was disappointed with the FDA’s actions, but planned to continue working with the agency to resolve the alleged problems.

Indian commerce and industry minister Kamal Nath and chemicals minister Ram Vilas Paswan sent letters to U.S. Secretary of Health and Human Development Michael Leavitt supporting Ranbaxy and asking for an early resolution of the case, according to an article in the India Economic Times. The Indian government would reportedly step in and contact the U.S. government if the ban on Ranbaxy drugs wasn’t lifted after the company took corrective action.

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