Aurobindo Pharma gets 3 observations from USFDA for Andhra Pradesh unit
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US Food and Drug Administration (USFDA) has issued Form 483 with three observations after inspecting Aurobindo Pharma’s manufacturing facility at Pydibhimavaram in Andhra Pradesh. As per 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. Subsequently, the company 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. The company will respond to the USFDA within the stipulated timeline and work closely with the regulator to address the observations at the earliest.
Aurobindo Pharma is engaged in manufacturing pharmaceutical products. It offers active pharmaceutical ingredients, intermediates and generic formulations like astemizole, domeperidone and omeprazole; anti-infective, oral and sterile antibiotics, pain management and osteoporosis segments.
