Cipla Ltd announced on Wednesday (November 13) that the United States Food and Drug Administration (US FDA) has issued eight observations following an inspection of the company’s manufacturing plant in Virgonagar, Bengaluru.

The inspection, which took place from November 7 to 13, concluded with the issuance of Form 483, a document describing conditions that the regulator believes may need to be improved to comply with manufacturing practices.

In a filing with the stock exchanges, Cipla confirmed its commitment to fully respond to the FDA’s comments within the required time frame. The company said it will work closely with the FDA to ensure each point is addressed comprehensively.

The observations come at an important time for Cipla, which reported a consolidated net profit of ₹1,303 crore for the quarter ended September, driven by revenue of ₹7,051 crore. However, shares of Cipla closed 1.3 per cent lower on Wednesday at ₹1,505.60 on the National Stock Exchange.

ALSO READ: Galaxy Surfactants: “We may have to wait another 2 quarters for urban demand to return”