Aurobindo Pharma arm’s North Carolina unit gets 11 U.S. FDA observations  

An inhalers and derma products manufacturing plant of Aurobindo Pharma subsidiary Aurolife Pharma LLC in the U.S. has been issued 11 observations by the United States Food and Drug Administration.

The U.S. FDA conducted an inspection at Raleigh plant, North Carolina, USA, owned by wholly owned step-down subsidiary Aurolife Pharma LLC from March 24 to April 10 and issued a Form 483 with 11 observations. These observations are procedural in nature. The development is not expected to have any material impact on the current business operations or existing supplies from the facility, Aurobindo Pharma said in a filing on Friday.

“We will submit a comprehensive response to the U.S. FDA within the stipulated timeline, addressing each observation with appropriate corrective and preventive actions,” it said.