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Dr Reddy’s Laboratories on Wednesday said the US health regulator has issued a Form 483 with three observations after inspecting its Production facility in Middleburg, New York. The audit of the business’s active pharmaceutical ingredients (API) manufacturing plant at Middleburg, New York has been completed from the US Food and Drug Administration (USFDA), the Hyderabad-based drug major said in a regulatory filing.
“We’ve been issued a Form 483 with 3 (three) observations. We’ll address them comprehensively within the specified timeline. Currently, we don’t have any sales from this plant,” it added.
According to the USFDA, Form 483 is issued to firm management at the conclusion of an inspection when investigators have observed some conditions that in their judgment may constitute violations of the Food Drug and Cosmetic Act and related acts.
Shares of the company on Wednesday ended 1.15 percent up at Rs 4,498.65 apiece on the BSE.
