BackDr Reddy’s says FDA raises concerns about its Andhra plant
The firm said it received 'inspectional observations' from the FDA after the agency's staff inspected its plant in Andhra Pradesh
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Mumbai: Drug maker Dr Reddy’s Laboratories Ltd has received a letter from the US Food and Drug Administration (FDA) highlighting concerns about its manufacturing plant in Andhra Pradesh, the company said on Thursday.
Dr Reddy’s said it received “inspectional observations" from the FDA after the agency’s staff inspected the plant. It was not immediately clear what the observations referred to, and a spokeswoman for Dr Reddy’s did not immediately respond to a request for comment.
FDA typically lists such observations in a “Form 483", which outlines conditions or practices at a drug-making unit that may cause the products made there to be in violation of the FDA’s standard production requirements.
Dr Reddy’s said the plant makes drug ingredients, but the company does not currently have any “activity" there. The FDA’s letter is not expected to have any material impact on the company’s financial results, it added.
Dr Reddy’s said it was “committed to" responding to the agency soon and will start implementing remedial measures immediately.
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