Aurobindo Pharma has received a significant regulatory boost with the United States Food and Drug Administration (US FDA) formally closing its 2022 Warning Letter issued to the company’s Unit-I facility. The development comes after the regulator completed a detailed evaluation of the company’s corrective actions and compliance measures.
The US FDA had carried out a for-cause inspection at Unit-I, an API manufacturing site operated by Apitoria Pharma Private Limited, a wholly owned subsidiary of Aurobindo Pharma. The inspection took place between August 21 and August 29, 2025, and resulted in a Form 483 containing five observations.
Following the inspection, Aurobindo Pharma submitted a comprehensive response outlining the corrective steps taken to address both the 2022 Warning Letter and the five observations from the Form 483. The US FDA has now confirmed that all concerns have been adequately resolved. As a result, the agency has issued an Establishment Inspection Report (EIR), classifying the facility under the “Voluntary Action Indicated” (VAI) category, which essentially means that no further regulatory action is required.
The company received the official communication from the US FDA on November 13, 2025. With this classification, the inspection is considered closed, and the unit is now back in good regulatory standing.
Aurobindo Pharma noted that the closure of the Warning Letter and the VAI status will have a positive impact on the Unit-I operations going forward. Improved compliance status typically strengthens business continuity, regulatory credibility, and approval timelines for future products.
