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Fiber Found on Drug Tablet Prompts FDA to Impose Alert on India’s Leading Drug Maker

Filed September 18th, 2013 Laurie

While visiting a Ranbaxy Laboratories Ltd. Facility last year, U.S. inspectors came across a black fiber embedded in a pill tablet that may have been a hair from an employee’s arm.

The discovery of the fiber and other quality issues at the facility belonging to India’s leading drug maker prompted the U.S. Food and Drug Administration (FDA) to impose an “import alert” on the Mohali plant last week. The agency said the factory had not ensured manufacturing quality, according to Reuters.

The Indian generic drug industry has faced numerous hurdles recently, including American regulatory reprimands, even as the U.S. demand for generic drugs grows, particularly under President Barack Obama’s new healthcare plan, Reuters reported.

According to Reuters, the FDA alert bans Ranbaxy from making FDA-regulated drugs at the Mohali facility and selling them in the U.S. until it is able to comply with good manufacturing standards. A few months ago, Ranbaxy pleaded guilty to U.S. felony charges related to drug safety and agreed to pay $500 million in fines. Inspectors found torn data records in a waste heap and urinals that emptied into an open drain in a bathroom six meters from the entrance to a sterile manufacturing area.

Documents show that during one of last year’s visits to the Mohali plant, health inspectors concluded that a black fiber embedded in a tablet was either “tape remnants on the nozzle head of the machine or a hair from an employee’s arm that could be exposed on loading the machine,” Reuters reported.

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