The action follows the recent inspection of the facility by the USFDA in August 2021, the drugmaker said in a stock exchange filing.
Shares of Hyderabad-based drugmaker Aurobindo Pharma fell as much as 4.5 per cent to hit an intraday low of Rs 685.85 after it received a warning letter from the US drug regulator - US Food and Drug Administration (USFDA) for its Hyderabad-based Unit I, an active pharmaceutical ingredient (API) manufacturing facility.
The action follows the recent inspection of the facility by the USFDA in August 2021, the drugmaker said in a stock exchange filing.
"The company believes that this will not impact the existing business from this facility," it noted.
The drugmaker stated that it will be engaging with the regulator and is fully committed to resolving the issue at the earliest.
The company is committed to maintaining the highest quality manufacturing standards at all of its facilities across the globe, it noted.
A warning letter is issued when the US health regulator finds that a manufacturer has significantly violated its regulations.
The letter identifies the violation, such as poor manufacturing practices, problems with claims for what a product can do, or incorrect directions for use.
The letter also makes clear that the company must correct the problem and provides directions and a timeframe of its plans for correction.
FDA then checks to ensure that the company's corrections are adequate.
(With PTI inputs)