(FDA: Rockville, Maryland) -- Due to quality control problems at two Ranbaxy Laboratories Ltd. manufacturing plants in India, the U.S. Food and Drug Administration (FDA) issued two warning letters and an import alert for generic drugs produced by the company.

“With this action we are sending a clear signal that drug products intended for use by American consumers must meet our standards of safety and quality,” says Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. “The FDA has notified other agencies and health care professionals to make them aware of today’s actions so that they can take appropriate action and advise patients as needed.”

Ranbaxy’s issues relate to deficiencies in the company’s drug manufacturing process at manufacturing facilities in Dewas and Paonta Sahib (including the Batamandi unit), in India.

One warning letter addressed problems at Ranbaxy’s Dewas facility found during an inspection conducted by FDA in early 2008. During that inspection, FDA investigators documented significant cGMP deviations in the manufacture of sterile and nonsterile finished products, and violations with respect to the manufacture and control of active pharmaceutical ingredients. Specific areas of concern included the following aspects of the firm’s quality control program:

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