Aurobindo Pharma Anakapalli facility gets 4 USFDA observations
Hyderabad: Aurobindo Pharma has announced that the company has received four observations from the United States Food and Drug Administration (US FDA) after the inspection at the Company’s Unit XIV, an API Non-antibiotic Manufacturing facility situated at Paravada Industrial Area, Anakapalli District, Andhra Pradesh.
The inspection was held from 15th May to 19th May 2023.
"At the end of the inspection, we have been issued a ‘Form 483’ with Four observations. The observations are procedural in nature." the company stated in a BSE filing.
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.
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 24 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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