Ranbaxy again falls foul of US FDA, which calls for new plant assessment

The US Food and Drug Administration has asked Indian pharmaceutical major Ranbaxy Laboratories to immediately assess the manufacturing practices at its plants that make drugs for the American market, saying the company has failed to adequately address the concerns raised by it earlier.

In February 2009, the FDA announced that a facility owned by Ranbaxy falsified data and test results in approved and pending drug applications. The facility, Paonta Sahib, has been under an FDA Import Alert since September 2008.
'FDA expects Ranbaxy to immediately undertake a comprehensive assessment of its global manufacturing operations to ensure that all sites manufacturing drug for the US market conform to US requirements,' said the FDA in issuing its latest warning letter.

The warning will not have any immediate financial impact on the company, majority-owned by Japanese drug major Daiichi Sankyo, as it is not accompanied by a ban on the drugs made at the plant, notes a report in India's Economic Times. It is not known how many FDA-approved facilities the company has globally. But, in the USA alone, it has at least three such plants, two of which were cleared by the agency during a recent inspection, while one received the warning letter. The Indian drugmaker said it had nothing to add beyond the statement it had issued on December 24 at the time of receiving the warning letter from the FDA. The FDA's warning letter was posted on the regulator's web site on February 3.