By: IPP Bureau
Last updated : September 23, 2022 12:07 pm
The plant at Raleigh, North Carolina, USA owned by Aurolife Pharma has received an establishment inspection report (EIR)
Following the product specific Pre-Approval Inspection (PAI) by the United States Food and Drug Administration (USFDA) at the Indore plant from 27th June, 2022 to 1st July, 2022, the company has now received the Establishment Inspection Report (EIR) indicating closure of the inspection.
Completion of US FDA inspection at Aurobindo's Raleigh Plant
The plant at Raleigh, North Carolina, USA owned by Aurolife Pharma LLC, a wholly owned step-down subsidiary of Aurobindo Pharma Limited has received an establishment inspection report (EIR) mentioning the inspection a voluntary action initiated (VAI) from the United States Food and Drug Administration (US FDA) and with this the US FDA pre-approval inspection and GMP inspection are concluded.