Aurobindo Pharma gets 3 USFDA observations for Andhra Pradesh facility
Hyderabad: Aurobindo Pharma has recently announced that the United States Food and Drug Administration (USFDA) has issued FORM 483 with 3 observations after the inspection at its Andhra Pradesh facility.
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.
"At the end of the inspection, we have been issued a 'Form 483' with 3 observations and none of these observations are related to data integrity," the company stated in its BSE filing.
"We will respond to the USFDA within the stipulated timeline and work closely with USFDA to address the observations at the earliest," the company added.
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 155 countries.
The company has 27 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.
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