FDA Issues Warning Letters and Import Alert for Drugs Produced by Ranbaxy

By Aaron Poehler

Published on September 16, 2008

The Food and Drug Administration (FDA) today issued warning letters to drug manufacturer Ranbaxy Laboratories Ltd. due to concerns about deviations from U.S. current Good Manufacturing Practice requirements at two of the company's manufacturing facilities.

Ranbaxy's Dewas and Paonta Sahib plants in India, which produce more than 30 different generic drug products, have been identified as having deficiencies in their drug manufacturing process, though no evidence that Ranbaxy has shipped defective products has surfaced to date. Among the specific FDA complaints regarding the facilities were inadequate batch production and control records, inadequate failure investigations, and inadequate procedures to prevent the potential for cross-contamination of pharmaceuticals.

Today's FDA Import Alert covers more than 30 different generic drug products produced at these two Ranbaxy locations and allows U.S. officials to detain said products at the U.S. border. However, drugs produced at Ranbaxy's other facilities are not covered by the Alert, no currently-available products will be removed from the market, and FDA officials urged consumers taking Ranbaxy-produced medications to continue and not disrupt their therapy.

Ranbaxy is among the largest of foreign suppliers of generic drugs to the United States. In 2006, the FDA issued a Warning Letter to Ranbaxy over violations of U.S. current Good Manufacturing Practice requirements at the Paonta Sahib facility.

 

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