The FDA banned the Indian manufacturing plant where Ranbaxy Laboratories made its generic version of Lipitor last year after citing the plant for a list of problems. The year before, the drugmaker recalled 41 lots of atorvastatin over the chance that ground-up glass had gotten into some of the active ingredient. But the fact that the plant is not currently shipping products to the U.S. has not kept Ranbaxy from having to recall more generic Lipitor.
According to an FDA enforcement report, the Indian drugmaker is voluntarily recalling nearly 65,000 bottles of atorvastatin calcium in the U.S. after a pharmacist reported finding a 20-milligram tablet in a sealed bottle marked for 10-milligram pills.
It is just the latest problem for the generic drugmaker. In January, the FDA banned Ranbaxy's key active pharmaceutical plant in Toansa, India, after a January follow-up inspection. 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 the company database. Proper analysis procedures were not followed, and equipment was not properly calibrated.
With that action, the last of Ranbaxy's four FDA-approved plants in India has now been banned from shipping to the U.S. Two plants had been banned in 2008 after issues were flagged for the FDA by a whistleblower, and the plants were placed under an extensive consent decree. In May 2013, Ranbaxy reached a $500 million settlement with U.S. authorities for those problems, pleading to several felony charges and pledging to weed out the manufacturing problems that led to them. The drugmaker now has only its Ohm Laboratories plant in New Jersey able to make products for the U.S. market.
All four of the banned manufacturing facilities have been placed under the 55-page consent decree that Ranbaxy and its parent Daiichi Sankyo agreed to in 2011. The decree outlines tight controls on manufacturing and requires 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. But problems have persisted, leading a Daiichi Sankyo exec to remark in January that more "drastic measures" are obviously needed to eradicate problems at the Indian drugmaker.
- here's the FDA Ranbaxy notice