Aurobindo Pharma gets USFDA EIR for Hyderabad facility
New Delhi: Aurobindo Pharma has recently announced that the company has received an Establishment Inspection Report (EIR) from the USFDA with Voluntary Action Initiated (VAI) status at the conclusion of the inspection of the company's Unit VII, an oral manufacturing facility situated at Jedcherla, Hyderabad.
Voluntary Action Indicated (VAI) means objectionable conditions or practices were found but the agency is not prepared to take or recommend any administrative or regulatory action.
"The Company's Unit VII, an oral manufacturing facility situated at Jedcherla, Hyderabad, received an Establishment Inspection Report (EIR) mentioning the inspection a Voluntary Action Initiated (VAl) from the USFDA and with this inspection is concluded," the company stated in BSE filing.
Medical Dialogues Team had earlier reported that the USFDA had concluded an inspection with six observations at its Unit VII, an oral manufacturing facility situated at Jedcherla, Hyderabad.
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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