USFDA makes 13 observations against Alkem’s Daman plant

By: | Published: September 29, 2016 6:34 PM

Drug firm Alkem Laboratories today said it has received inspection report with thirteen observations from the US health regulator after the inspection of its manufacturing facility at Daman.

Ajanta Pharma-reuters LThe company has received the inspection report which contains thirteen observations, it added. (Source: Reuters)

Drug firm Alkem Laboratories today said it has received inspection report with thirteen observations from the US health regulator after the inspection of its manufacturing facility at Daman.

“The United States Food and Drug Administration (USFDA) had conducted an inspection at the company’s manufacturing facility located at Daman from September 20 to September 29, 2016,” Alkem Laboratories said in a filing to BSE.

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

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 Act and related Acts.”

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

Shares of Alkem Laboratories today closed at Rs 1,804.05 per scrip on BSE, down 2.05 per cent from its previous close.

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