Aurobindo Pharma on Tuesday said that the U.S. health regulator has issued Form 483 with three observations after inspecting its manufacturing facility at Pydibhimavaram in Andhra Pradesh.
As per the U.S. Food and Drug Administration, Form 483 is issued to a firm's management at the conclusion of an inspection when the investigator has observed any conditions that in its judgement may constitute violations of the Food Drug and Cosmetic Act and related Acts.
"The Pydibhimavaram unit was classified as official action indicated on May 17, 2019, and subsequently given a warning letter on June 20, 2019 by the U.S. FDA", Aurobindo Pharma said in a regulatory filing.
Subsequently, the company said that it has responded to the warning letter and carried out the committed corrections and the U.S. FDA authorities inspected the facility from July 25 to Aug. 2, 2022.
"At the end of the inspection, we have been issued a Form 483 with three observations and none of these observations are related to data integrity," Aurobindo Pharma said.
The company will respond to the U.S. FDA within the stipulated timeline and work closely with the regulator to address the observations at the earliest, it added.
The unit is a non-antibiotic active pharmaceutical ingredients manufacturing facility.
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