Alkem Labs hit with FDA 483 with three observations at Indian plant

By Dan Stanton contact

- Last updated on GMT

Image: iStock/Lemiuex
Image: iStock/Lemiuex

Related tags: States and territories of india, Food and drug administration, Fda

The US FDA has issued a Form 483 with three observations to Alkem Laboratories after an inspection at its facility in Himachal Pradesh, India.

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.

Related topics: Regulatory & Safety, Regulations, QA/QC

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