Aurobindo Pharma Completes US FDA Inspection with 8 Procedural Observations at Unit-XII

Aurobindo Pharma Ltd. has recently completed a US FDA inspection at its Unit-XII, which includes both oral solids and injectable manufacturing units in Telangana, India. The inspection took place from August 25 to September 05, 2025. At the end of the current inspection, a ‘Form 483’ was issued with a total of 8 observations for both (oral solids & injectable). All observations are procedural in nature, and the company will respond to the US FDA within the stipulated timelines. Aurobindo Pharma is committed to maintaining the highest quality manufacturing standards at all of its facilities across the globe. There is no impact on the Company’s financials or operations due to the said action.