Institute of Good Manufacturing Practices India®

USFDA issued a warning letter to the New Jersey unit of Aurobindo Pharma's subsidiary


The United States Food and Drug Administration (USFDA) issued a warning letter to the drug manufacturing company Aurobindo Pharma's step-down subsidiary. The warning was issued to the manufacturing facility of AuroLife Pharma situated at Dayton, New Jersey. 

AuroLife Pharma is a wholly-owned step-down subsidiary of Aurobindo Pharma. This warning letter follows an earlier letter with OAI (Official Action Indicated) status issued on June 4, 2020. 

Aurobindo Pharma is willingly coordinating with the USFDA to resolve the issue on priority. There may not be any impact on the present business of the said facility of the company, as per the company's claim.