Ranbaxy’s repeat violation elicits swift FDA action
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
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