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# FDA Aurobindo Pharma Inspection Has 7 Observations
- URL: https://www.fdaweb.com/fda-aurobindo-pharma-inspection-has-7-observations/
- Published: 2021-08-24T12:00:00.000Z
- Updated: 2026-09-14T17:11:37.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5149997

FDA has released the FDA-483 issued following an 8/2-8/12 agency inspection at the Aurobindo Pharma Unit 1 active pharmaceutical ingredient manufacturing facility in Doultabad, Telangana, India. The 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.