Quality Control Breakdown at Ranbaxy Manufacturing Plants

(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:

• The facility’s beta-lactam containment program (measures taken to control cross-contamination), which appeared inadequate to prevent the potential for cross-contamination of pharmaceuticals
• Inadequate batch production and control records
• Inadequate failure investigations (A failure investigation is done to address any manufacturing control or product rejection to determine the root cause and prevent recurrence)
• Inadequate aseptic (sterile) processing operations

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

• 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

Ranbaxy is one of the largest foreign suppliers of generic drugs to the United States. The company makes a number of drug products. Including Ganciclovir oral capsules (an antiviral drug), of which Ranbaxy is the sole distributor. These actions are proactive measures that the FDA is taking to assure that all drugs that reach the American public are manufactured according to cGMP requirements. This action doesn’t involve removing products from the market, as FDA has no evidence to date that Ranbaxy shipped defective products.

For further information, visit www.fda.gov/bbs/topics/NEWS/2008/NEW01886.html.