The Baddi facility was visited by a US Food and Drug Administration (FDA) inspection team between March 2nd and 10th resulting in a report containing three observations.
“The Company shall put together a detailed report with adequate corrective and preventative measures to address the US FDA Observations and the same is proposed to be filed within the timeline stipulated by US FDA,” Alkem Laboratories said in a filing submitted to the Bombay Stock Exchange Friday.
The firm was not available for immediate comment.
The inspection comes three months after the FDA issued a Form 483 at another Alkem site in Ankleshwar, Gujarat also citing three observations. A bio-analytical inspection at the firm’s facility in the Daman and Diu state was inspected in October, with the FDA making no observations.
Alkem owns and operates 14 manufacturing facilities in India and two in the US.