Dr. Reddy’s Gets Three Observations From U.S. FDA For New York Facility
Dr. Reddy’s Laboratories Ltd. on Wednesday said the U.S. drug regulator has issued a Form 483 with three observations after inspecting its manufacturing facility in Middleburg, New York.
The audit of the company's active pharmaceutical ingredients manufacturing plant at Middleburg, New York has been completed by the U.S. Food and Drug Administration, the Hyderabad-based drug major said in a regulatory filing.
"We have been issued a Form 483 with 3 (three) observations. We will address them comprehensively within the stipulated timeline. Currently, we do not have any sales from this plant," it added.
As per the U.S. FDA, Form 483 is issued to firm management at the conclusion of an inspection when investigators have observed any 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% up at Rs 4,498.65 apiece on the BSE.