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# Aurobindo Hit with FDA-483 After Inspection
- URL: https://www.fdaweb.com/aurobindo-hit-with-fda-483-after-inspection/
- Published: 2022-08-04T12:00:00.000Z
- Updated: 2026-09-14T17:54:50.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5152443

FDA has issued a Form FDA 483 to Aurobindo Pharma that cites three observations after investigators inspected (7/25 to 8/2) the firm’s Unit XI, an active pharmaceutical ingredient manufacturing facility in Pydibhimavaram, a district of Andhra Pradesh, India. “At the end of the inspection, we have been issued a Form 483 with 3 observations and none of these observations are related to data integrity,” the company said in a stock exchange statement.

Aurobindo has received increased FDA scrutiny over the past several years, including two Warning Letters issued within two years. One letter was over GMP deficiencies cited 8/2021 at its Hyderabad, India-based Unit 1 active pharmaceutical ingredient manufacturing facility. 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 most recent Warning Letter followed a 10-day agency inspection at the API facility. 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 response to the latest Form 483, the company said it will work with FDA to fully resolve the issues in a timely manner.