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FDA Bans Another Ranbaxy Facility from Distributing Drugs to US

By Burg Simpson
February 2, 2014
3 min read

The U.S. Food and Drug Administration has prohibited Indian multinational pharmaceutical company Ranbaxy Laboratories, Ltd. from producing and distributing drugs and supplies produced at its Toansa, India, facility to the United States. The Jan. 23 decision by the FDA came after the agency’s inspectors discovered numerous violations at the plant earlier this month.

Violations include Toansa staff retesting raw materials, intermediate drug products and finished active pharmaceutical ingredients (APIs) after the products had already failed analytical testing and specifications. The company reportedly tried to produce “acceptable findings” by retesting these items, and did not disclose the initial failures, FDA reported. These are “significant” current good manufacturing practice (CGMP) violations, the FDA said.

“We are taking swift action to prevent substandard quality products from reaching U.S. consumers,” said Carol Bennett, acting director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research. “The FDA is committed to ensuring that the drugs American consumers receive – no matter where they are produced – meet quality standards and are safe and effective.”

The FDA placed a consent decree of permanent injunction on Ranbaxy’s other India plants in January 2012, conditions of which the company’s Toansa facility will be subject to. Along with not being able to distribute or export its drugs to the U.S., the company’s Toansa’s facility is not allowed to provide APIs to other companies who make products for U.S. consumers, the FDA said. Toansa supplies are used to produce many critical ingredients used in Ranbaxy’s generic products, The Wall Street Journal reported.

Details on violations
During its investigation at the Toansa facility, FDA inspectors found sticky notes that had directions for “corrections to be made to the raw data,” for testing, the WSJ reported. Inspectors also saw a worker in a quality control lab backdating a log entry.

“We immediately questioned this analyst regarding the reason for backdating his record, who responded that he had only entered ‘2014,’ despite our visual observation of him entering a signature and full date entry a few moments earlier,” the FDA report said.

FDA inspectors also discovered the Toansa plant’s analytical and microbiological laboratories were in “significant disrepair.” Some windows in the labs would not shut, and a sample preparation room had so many flies that were “too numerous to count,” the FDA’s report said, according to the WSJ.

Possible drug shortage
The FDA said it is determining if the action against Ranbaxy will create a drug shortage in the United States. Should an issue arise, the FDA said it may modify its order against the company to allow patients access to drugs manufactured under controls that are “sufficient to assure quality, safety and effectiveness.” The federal agency also recommends patients do not stop taking any medication or disrupt their drug therapy, as that could adversely impact their health.

Ranbaxy currently accounts for 71 percent of the U.S. market for hydroxychloroquine – a drug used to treat and prevent malaria, the WSJ reported.

Previous problems with drug maker
The consent decree was initially ordered against Ranbaxy in January 2012 due to manufacturing quality issues, according to the WSJ. The order was aimed at encouraging the company to make the proper steps to ensure products produced at their three Indian plants and one in New York were safe for consumers.

However, problems with the company’s manufacturing persisted. In September 2013, the FDA blocked imports from Ranbaxy plant in Mohali, India, the WSJ reported.

The Toansa plant will remain under the FDA’s restrictions until its problems are fixed.

Additional resources: Dangerous medicine, Product liability lawyer

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