US FDA descends on Sun Pharma's Halol unit.

Drug maker Sun Pharma's manufacturing facility in Halol (Gujarat) is undergoing a surprise inspection by the US Food and Drug Administration (US FDA), it is learnt. The move may have been triggered by a number of recent recalls from the plant, sources, familiar with the development, said.

When contacted on phone, Sun Pharma spokesperson declined to comment.

In May, Sun Pharma's another manufacturing facility in Karkhadi, also in Gujarat, had received a warning letter from the US FDA after investigators identified violations of current good manufacturing practice and regulations for finished pharmaceuticals.

The American regulator, in its warning letter to Sun Pharma's Karkhadi plant, had also asked the company to expand its 'internal review to any other facilities determined to be involved in, or affected by, inaccurate data reporting'.

Sources said the latest inspection could have been triggered because despite the warning letter at Karkhadi plant, recalls by the company continued from Halol plant, which supplies significant amount of medicines to the US.

Of late, Sun Pharma recalled three important medicines from the US market. It recalled 40,000 bottles of Venlafaxine Hydrochloride extended-release tablets after it failed dissolution test. The company also recalled Gemcitabine for manufacturing issue (lack of sterility assurance) and Metformin for packaging problems (Gabapentin tabs found in Metformin bottles).

BS