Daijiworld Media Network - New Delhi

New Delhi, Apr 20: Major pharmaceutical company Lupin Limited has reported that the US drug regulator has issued a Form 483 with three observations following an inspection at its manufacturing facility in Somerset, New Jersey.

In a regulatory filing, the company stated that the inspection was conducted by the US Food and Drug Administration between April 13 and April 17. The inspection concluded with the issuance of a Form 483, highlighting three observations related to compliance.

Lupin said it will review the observations and submit a formal response to the regulator within the stipulated timeline. The company also reaffirmed its commitment to maintaining compliance with current Good Manufacturing Practices (cGMP) across all its facilities worldwide.

Earlier in March, the USFDA had inspected Lupin’s Ankleshwar manufacturing plant in India between March 2 and March 7, which resulted in a Form 483 with two observations. The company had similarly stated at the time that it would address the issues and respond within the required period while ensuring adherence to regulatory standards.

A Form 483 is issued by USFDA inspectors when they observe conditions that may potentially violate the Food, Drug, and Cosmetic Act or related regulations. It serves as an official communication of inspectional observations made during facility audits.

Following the development, Lupin’s stock closed slightly lower on the National Stock Exchange, while continuing to trade near its 52-week range, with market movements reflecting cautious investor sentiment amid regulatory updates.