Alkem Labs under the scanner: three, 483 observations on file; stock dives 6 %

Mumbai based pharmaceuticals major, Alkem Laboratories today in an exchange filing informed exchanges that the company has received three, 483 observations for its API (active pharmaceuticals ingredients) facility in Ankleshwar, Gujarat.

The facility under the scanner was inspected by the US health care officials from December 5 to 9, 2016.

An FDA Form 483 is issued to firm management at the conclusion of an inspection, when an investigator(s) has observed any conditions that in their judgement may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.

Companies are encouraged to respond to the FDA Form 483 in writing with their corrective action plan and then implement that corrective action plan expeditiously.

The company shall put together a detailed response with adequate corrective and preventive measures to address the USFDA observations and the same is proposed to be filed within the time line stipulated by the US health regulator, said Alkem Laboratories.

Owing to the announcement, shares of Alkem Laboratories have declined by six per cent at Rs 1599.05 on NSE.

In the last month or so there have been many Indian Pharma companies like Sun Pharma, Divi's Lab and Cipla, which have received form 483 from the US regulator, post inspection of their respective facilities.