FDA Adds Fourth Indian Site to Ranbaxy’s Consent Decree; Issues Import Alert

September 20, 2013

In an enforcement action industry experts say signals FDA doubts about the generic giant’s culture of quality, the agency Sept. 16 added Ranbaxy’s Mohali, India, facility to a consent decree it signed in January 2012 and issued an import alert on the plant, which makes oral solids.

The other Indian plants subject to the consent decree, Paonta Sahib, Batamandi and Dewas, have been on FDA import alert since September 2008. The consent decree also bars Ranbaxy from producing agency-approved drugs for the U.S. market at the Ohm Laboratories plant in Gloversville, N.Y., until manufacturing meets U.S. drug quality standards.

As with those facilities, Ranbaxy is required to have a third-party audit of Mohali conducted to certify that quality-control methods, processes and controls are adequate to resume production.

The regulatory tightening stems from FDA inspections of Mohali in September and December of last year, when investigators observed “significant [current good manufacturing practices (cGMP)] violations,” including failure to investigate manufacturing problems, the agency said.

“The FDA is committed to using the full extent of its enforcement authority to ensure that drugs made for the U.S. market meet federally mandated quality standards,” said Howard Sklamberg, director of CDER’s Office of Compliance.

Coming a year and a half after the consent decree was signed, the development was a surprise to some industry experts who said Ranbaxy should have learned from audits of its other facilities.

“You would think the U.S. market is especially important to Ranbaxy that it would compel compliance with FDA requirements,” Steve Niedelman, lead quality systems and compliance consultant with King & Spalding’s FDA and life sciences practice, said Monday. Niedelman noted that approximately 40 percent of generic drugs entering the U.S. market originate in India.

Other experts said the agency’s move Sept. 16 signaled a souring of expectations on the part of the FDA and its oversight of the Indian company.

If more sites are added to a consent decree, it may reflect a lack of confidence in the company’s quality system, Alan Minsk, a partner at Arnall Golden Gregory, said. In such cases, “there may be some commonality issues involved such as personnel or product concerns” representative of a pattern or a trend, he said.

In the consent decree it filed on behalf of the FDA, the U.S. Justice Department noted that “Ranbaxy has a history of continuing [cGMP] violations.”

“The drug cGMP deviations observed at Paonta Sahib, Batamandi, Dewas, and Gloversville are all similar, and demonstrate that the firm has not established and documented management control over quality assurance and quality control functions at these facilities,” the agency said at the time.

As part of a comprehensive remediation plan, Ranbaxy has invested more than $300 million in new manufacturing equipment and increased quality management staff — moves the FDA continually urges manufacturers to make to prevent quality-related problems.

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