Aurobindo Pharma on Friday said it has received a warning letter from the US health regulator for its Hyderabad-based Unit I, an API (active pharmaceutical ingredient) manufacturing facility.
The action follows the recent inspection of the facility by the US Food and Drug Administration (USFDA) in August 2021, the drugmaker said in a regulatory 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.
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