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# Aurobino Pharma Gets 2nd Warning Letter in 15 months
- URL: https://www.fdaweb.com/aurobino-pharma-gets-2nd-warning-letter-in-15-months/
- Published: 2022-01-20T12:00:00.000Z
- Updated: 2026-09-14T17:29:16.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5150968

Aurobindo Pharma has been issued an FDA Warning Letter over GMP deficiencies cited 8/2021 at its Hyderabad, India-based Unit 1 active pharmaceutical ingredient (API) manufacturing facility. This is the second Warning Letter issued to the company in the past 15 months. Its U.S subsidiary, AuroLife Pharma, was issued a Warning Letter 10/2020 based on an inspection at its oral solid manufacturing facility in Dayton, NJ ([see story](https://www.fdaweb.com/aurolife-pharma-hit-with-warning-letter/)).   

The latest Warning Letter followed a 10-day agency inspection at the API facility in Doultabad, Telangana, India. An earlier-released FDA-483 [lists](https://www.fda.gov/media/151743/download?ref=fdaweb.com) these seven inspection observations: 

- systems for evaluating and qualifying critical material suppliers are inadequate;
- inadequate sampling plans for raw materials and intermediates;
- components used in manufacturing are not tested and released before use;
- proposed changes are not adequately evaluated;
- quality control failed to ensure that investigations made into any unexplained discrepancy were scientifically sound;
- equipment is not properly maintained; and
- quality-related activities are not documented at the time of performance.

In a financial filing, Aurobindo said that it “believes that this will not impact the existing business from this facility.” The company also said it will work with FDA to fully resolve the issues in a timely manner.