Aurobindo Pharma Faces USFDA Scrutiny with Form 483 Observations

Aurobindo Pharma's Unit-IV in Andhra Pradesh received a Form 483 with five observations from the USFDA after an inspection. The firm assured compliance within timelines and emphasized its commitment to high manufacturing standards. Shares saw a rise of 0.83% on the BSE.

Aurobindo Pharma announced that the US Food and Drug Administration (USFDA) issued a Form 483 containing five observations following an inspection of its Hyderabad subsidiary, APL Healthcare's Unit-IV. The inspection occurred from December 8 to December 17, 2025.

The observations are procedural in nature, and the company stated its intention to address them within the stipulated timeframe. Aurobindo Pharma emphasized its dedication to upholding the highest quality manufacturing standards worldwide.

The issuance of Form 483 often indicates potential violations of the Food Drug and Cosmetic (FD&C) Act. Following the news, shares of Aurobindo Pharma rose by 0.83% to Rs 1,203 each on the BSE.

(With inputs from agencies.)