Aurobindo Pharma: FDA Inspections at Multiple Units Yield Mixed Results
Aurobindo Pharma's Telangana API manufacturing unit received an Establishment Inspection Report (EIR) with a 'Voluntary Action Indicated' (VAI) classification from the FDA, indicating improvement from a previous warning letter. The FDA deemed the company's corrective actions adequate. Meanwhile, Eugia Pharma Specialities, a subsidiary, completed an FDA inspection at its Bhiwadi formulation facility, resulting in 9 procedural observations.
*this image is generated using AI for illustrative purposes only.
Aurobindo Pharma , a prominent player in the pharmaceutical industry, has received varying inspection results from the U.S. Food and Drug Administration (FDA) for its different manufacturing units.
Telangana Unit Receives Positive FDA Evaluation
Aurobindo Pharma has received an Establishment Inspection Report (EIR) for its manufacturing unit in Telangana, India. The FDA has classified the facility as 'Voluntary Action Indicated' (VAI), suggesting that while there are deficiencies that should be addressed, they are not considered serious enough to warrant immediate regulatory action.
Inspection Details
The inspection was conducted at Unit-I, an API manufacturing facility of Apitoria Pharma Private Limited, a wholly owned subsidiary of Aurobindo Pharma. The unit is located in Borpatla Village, Hatnoor Mandal, Sangareddy District, Telangana.
Inspection Timeline and Findings
| Date | Event |
|---|---|
| January 14, 2022 | Warning letter issued by FDA |
| August 21-29, 2025 | For-cause inspection conducted |
| August 29, 2025 | Form 483 issued with 5 observations |
| November 13, 2025 | EIR received with VAI classification |
The FDA's recent evaluation considered the corrective actions submitted by Aurobindo Pharma in response to both the January 2022 warning letter and the subsequent Form 483 observations. The regulatory body has determined that the issues cited in these documents have been adequately addressed.
Implications of VAI Classification
The VAI classification indicates that while the FDA found objectionable conditions during the inspection, these issues do not meet the threshold for regulatory or administrative action. Essentially, any deviations from quality standards are to be addressed voluntarily by the company.
Aurobindo Pharma has stated that this classification is expected to have a positive impact on the operations of the unit. The closure of the warning letter and the VAI classification suggest that the company has made significant progress in addressing the FDA's concerns.
Company's Response
In a regulatory filing, B. Adi Reddy, Company Secretary of Aurobindo Pharma, stated, "The U.S. FDA has now completed its evaluation of the corrective actions submitted in response to the Warning Letter dated January 14, 2022, including subsequent 5 observations from Form 483 and has determined that the issues cited have been adequately addressed."
Subsidiary's Bhiwadi Facility Inspection
In a separate development, Eugia Pharma Specialities, a subsidiary of Aurobindo Pharma, has completed an FDA inspection at its Unit-II formulation manufacturing facility in Bhiwadi.
Inspection Details and Findings
- Inspection Period: November 3-14, 2025
- Result: 9 procedural observations
Company's Statement
Aurobindo Pharma has stated that the observations will be addressed within the stipulated time and will not impact existing operations of the unit.
These developments highlight Aurobindo Pharma's ongoing engagement with regulatory authorities and its commitment to maintaining quality standards across its manufacturing facilities. While the Telangana unit has shown improvement, the company faces new challenges at its Bhiwadi facility.
Historical Stock Returns for Aurobindo Pharma
| 1 Day | 5 Days | 1 Month | 6 Months | 1 Year | 5 Years |
|---|---|---|---|---|---|
| -0.53% | +3.39% | +2.01% | +10.76% | -2.79% | +36.96% |
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