US FDA issues thirteen 483 observations for Alkem's Daman facility

Alkem Laboratories Ltd has received the inspection report for its Daman manufacturing facility from the US Food & Drug Administration (FDA) that contains thirteen 483 observations.

Form 483 is issued by US FDA to the company at the end of an inspection if the investigators observe any conditions that in their judgement may constitute violations of the Food Drug and Cosmetic (FD&C) Act. Normally, companies are asked to respond to the Form 483 in writing with their corrective action plan, which then needs to be implemented expeditiously.

Observations were issued to Alkem Laboratories following US FDA’s inspection at its manufacturing facility at Daman from September 20 to September 29, 2016.

“The company has received the inspection report which contains thirteen 483 observations. 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 US FDA,” said Alkem Laboratories in a BSE filing yesterday.