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# Aurobindo Pharma FDA-483
- URL: https://www.fdaweb.com/aurobindo-pharma-fda-483-2/
- Published: 2019-02-26T12:00:00.000Z
- Updated: 2026-09-15T01:07:54.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5143471

FDA has released the FDA-483 with two observations it issued following a 12/3-12/14/18 inspection at Aurobindo Pharma Unit 4, Hyderabad, Telangana, India. Specific inspection observations were: 

- failing to establish and follow procedures designed to prevent microbiological contamination of drug products purporting to be sterile; and
- failing to wear protective apparel as necessary to protect drug products from contamination.