As per US Food and Drug Administration (USFDA), 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 (FD&C) Act and related Acts.
Aurobindo Pharma on Tuesday said the US health regulator has issued Form 483 with three observations after inspecting its manufacturing facility at Pydibhimavaram in Andhra Pradesh.
As per US Food and Drug Administration (USFDA), 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 (FD&C) Act and related Acts.
The Pydibhimavaram unit was classified as OAI (official action indicated) on May 17, 2019, and subsequently given a warning letter on June 20, 2019 by the USFDA, Aurobindo Pharma said in a regulatory filing.
Subsequently, the company said it has responded to the warning letter and carried out the committed corrections and the USFDA authorities inspected the facility from July 25 to August 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 USFDA 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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First Published: Tue, August 02 2022. 22:17 IST