During an inspection of Ranbaxy Laboratories' key active pharmaceutical ingredient plant more than a year ago, plant officials were warned: Lock down access to a standalone computerized system so unauthorized workers couldn't mess with data. But in an inspection earlier this month, FDA investigators not only found that their directions had been ignored but they also uncovered evidence that what they feared would happen, the deletion of data, had in fact taken place. The response from Washington was swift and severe this time. Last week the FDA banned the API plant from shipping any more products to the U.S.
The API plant in Toansa, India, now joins Ranbaxy formulation plants in Mohali, Dewas and Paonta Sahib in India that are banned from shipping products to the U.S. The FDA made 8 observations during the Jan. 5 through Jan. 11 inspection of Toansa, according to a Form 483 inspection report the FDA posted publicly on Monday. Particularly troubling, the FDA said, was that workers at the plant had been retesting products that failed analytics until they got the results that were needed, overwriting the old results in its database. Proper analysis procedures were not followed, and equipment was not properly calibrated.
In terms of plant condition and sanitation, inspectors noted that a refrigerator where samples were stored was dripping, leaving a pool of water beneath it. They also said cabinets where important documents were stored were broken and didn't close. In addition, windows in the quality-control analytics lab could not be closed, allowing in flies "Too Numerous To Count." The FDA is not having the generic drugmaker pull products already on the market and is assessing what the ban will mean in terms of potential drug shortages.
The company said that it had "proactively suspended shipments" from the plant when it received the FDA Form 483 criticizing the facility. "This development is clearly unacceptable and an appropriate management action will be taken upon completion of the internal investigation," Ranbaxy CEO and Managing Director Arun Sawhney said in the statement.
The FDA earlier cut three Ranbaxy drug manufacturing plants off from shipping to the U.S. because of quality lapses, leaving the company with just its Ohm Laboratories plant in New Jersey still able to serve its largest market. But Ohm relies on APIs from the Toansa facility, which produced more than two-thirds of the APIs the drugmaker used for its U.S. products. The bans prevent any drug launches from those facilities, complicating Ranbaxy getting new products into the U.S., a market that in 2012 accounted for about 40% of its revenues.
In announcing its latest action against Ranbaxy, the FDA said the Toansa plant, like the three other banned facilities before it, will now fall under a 55-page consent decree that Ranbaxy and its parent Daiichi Sankyo agreed to in 2011. The decree outlines tight controls on manufacturing, requiring the company to bring in independent auditors to oversee its operations and to report directly to the FDA if they face any issues in doing their jobs.
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