Aurobindo Pharma's: unit gets FDA Form 483 with 8 observations

Aurobindo Pharma's: unit gets FDA Form 483 with 8 observations

Aurobindo Pharma Ltd, a leading pharmaceutical company, reported on Friday that the United States Food and Drug Administration (US FDA) has completed an inspection of its Unit-XII manufacturing facility at Bachupally, Telangana. The inspection, which covered both oral solids and injectable units, took place between August 25 and September 5, 2025. At the conclusion of the inspection, the FDA issued a Form 483 with eight procedural observations [1].

The company has clarified that these observations are procedural in nature and do not impact its financials or operations. Aurobindo Pharma stated that it will submit a detailed response to the FDA within the stipulated timelines. The company remains committed to maintaining the highest quality manufacturing standards across all its facilities worldwide [1].

Prior to the announcement, shares of Aurobindo Pharma closed at ₹1,048 on the NSE, up 1.16% or ₹12, indicating investor confidence in the company's ability to address the procedural observations [1].

References:
[1] https://www.cnbctv18.com/market/aurobindo-pharma-shares-us-fda-wraps-bachupally-plant-inspection-8-observations-ws-l-19665602.htm