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# Aurobindo Inspection Yields 2 Observations
- URL: https://www.fdaweb.com/aurobindo-inspection-yields-2-observations/
- Published: 2017-09-27T12:00:00.000Z
- Updated: 2026-09-14T22:52:59.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5139722

FDA has released the FDA-483 issued following an 8/28-9/1 inspection at the Aurobindo Pharma drug manufacturing plant in Hyderabad, Telangana, India. The two specific [observations](https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/CDERFOIAElectronicReadingRoom/UCM577372.pdf?ref=fdaweb.com) cited were: 

- failing to have written procedures for production and process controls designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess; and
- failing to establish control procedures that validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product.