Alkem Gets 3 Observations From US Regulator After Ankleshwar Unit Inspection

Alkem Gets 3 Observations From US Regulator After Ankleshwar Unit Inspection

The company said it has received the inspection report that contains three 483 observations.

New Delhi: Drug firm Alkem Laboratories on Monday said the US health regulator has issued three observations after inspection of the company's API facility at Ankleshwar in Gujarat.

"United States Food and Drug Administration (USFDA) had conducted an inspection at the company's API (Active Pharmaceutical Ingredient) manufacturing facility located at Ankleshwar from 5th December to 9th December, 2016," Alkem Laboratories said in a filing to stock exchange BSE.

The company has received the inspection report which contains three 483 observations, it added.

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

According to the US regulator, observations are made in Form 483 when investigators feel that conditions or practices in the facility are such that products may become adulterated or render injuries to health.

The FDA Form 483 notifies the company's management of objectionable conditions.

At 12:58 p.m., shares in Alkem Laboratories were trading 3.67 per cent lower at Rs 1,613.85 apiece on the BSE, whose benchmark Sensex index was down 0.54 per cent.
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