Alkem's Ankleshwar APIs facility receives three 483 observations from US FDA

Alkem Laboratories Ltd has received three 483 observations from the US Food and Drug Administration (FDA) for its APIs (active pharmaceutical ingredients) manufacturing facility located at Ankleshwar (Gujarat). This follows an inspection conducted by US FDA at the site from December 5-9, 2016.

“The company has received the inspection report which contains three 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 in a BSE filing.

An FDA 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.