United States regulators discovered a black fiber in a tablet produced by drug maker, Ranbaxy Laboratories Ltd., in 2012, leading to a just-announced import ban.
The black fiber may have been a hair from a worker’s arm, according to papers seen by Reuters concerning this and other issues at India’s largest drug manufacturing facility. The black hair or fiber and other quality issues have resulted in a so-called “import alert” by the U.S. Food and Drug Administration (FDA) on the Ranbaxy’s Mohali plant, which says that the drug maker had not ensured manufacturing quality. Ranbaxy is majority owned—63.5 percent—by Daiichi Sankyo Co. of Japan and receives more than 40 percent of its sales from the U.S., according to Reuters.
The import alert bans Ranbaxy from manufacturing FDA-regulated drugs at its Mohali plant and selling drugs in the U.S. until the drug maker’s methods, facilities, and controls come into compliance with good manufacturing standards, Reuters wrote. The move puts three of Ranbaxy’s India plants under sanction—the three facilities are focused on supplying the U.S. with drugs. The sanctions came after agency inspections that took place in September and December 2012, Reuters reported.
At one inspection, the federal regulator concluded that the black fiber 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,” the documents revealed, according to Reuters. Last November, the drug maker recalled its generic version of Lipitor in the U.S. over potential glass particles in some batches.
The tablet was also not within the specified weight limit, according to FDA inspection documents. The agency also found dirty glassware, a potential packaging line failure that led to unlabeled bottles being sent to pharmacies, and spots and abrasions on the surface of tablets made at the facility, wrote Reuters.
The move, explained Business Insider, extended an existing consent decree for Ranbaxy’s Paonta Sahib (Himachal) and Dewas (Madhya Pradesh) units to now include its third facility at Mohali. “The Mohali facility be subject to certain terms of the consent decree of permanent injunction entered against Ranbaxy in January 2012,” the FDA announced. The agency will re-inspect the location before the ban will be lifted.
The FDA also stated that Ranbaxy must hire a third-party consultant to thoroughly inspect and certify the Mohali facility. Experts estimate the process to take at least two to three years, according to Business Insider.
The moves might leave Ranbaxy unable to file new applications and the drug maker will also likely be unable to realize 16-18 pending applications filed from Mohali seeking generic drug approval, including generic versions of Diovan, Valcyte, and Nexium over the next year, wrote Business Insider.