Aurobindo Pharma gets 3 USFDA observations for Telangana facility
Telangana: Aurobindo Pharma has announced that the United States Food and Drug Administration (US FDA) has issued ‘Form 483’ with 3 observations at the conclusion of an inspection at the Company's Unit III, a Formulation manufacturing facility situated at Bachupally Village, Medchal Malkajgiri District, Telangana.
An FDA Form 483 is issued to firm management at the conclusion of an inspection when an investigator(s) has observed any conditions that in their judgment may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.
The inspection was conducted from 14th July to 21st July 2023.
"The observations are procedural in nature. We will respond to the US FDA within the stipulated timelines and work closely with US FDA to close the observations at the earliest," the company stated in a BSE filing.
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Aurobindo Pharma Limited is an integrated global pharmaceutical company headquartered in Hyderabad, India. The Company develops, manufactures, and commercializes a wide range of generic pharmaceuticals, branded specialty pharmaceuticals and active pharmaceutical ingredients globally in over 150 countries. The company has 25 manufacturing and packaging facilities that are approved by leading regulatory agencies including USFDA, UK MHRA, EDQM, Japan PMDA, WHO, Health Canada, South Africa MCC, Brazil ANVISA. The company’s product portfolio is spread over 7 major therapeutic/product areas encompassing CNS, AntiRetroviral, CVS, Antibiotics, Gastroenterological, Anti-Diabetics and Anti-Allergic.
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