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# Aurobindo India Plant Hit With Form-483
- URL: https://www.fdaweb.com/aurobindo-india-plant-hit-with-form-483/
- Published: 2017-04-19T12:00:00.000Z
- Updated: 2026-09-14T22:18:40.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5138481

FDA has concluded a 4/10-18 inspection at Aurobindo Pharma’s formulations manufacturing facility at Bachupally in Hyderabad, India that resulted in a six-item Form-483\. “The observations are all on procedural improvements,” the company said. “None of them are related to data integrity.” 

A 10/17-10/25/16 FDA inspection at Aurobindo’s Borpatla Village, India, facility found that equipment cleaning procedures were not adequately validated, a January-posted [Form-483](http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/CDERFOIAElectronicReadingRoom/UCM535801.pdf?ref=fdaweb.com) showed. Aurobindo has six formulations manufacturing facilities in India, one each in the U.S. and Brazil. The Bachupally unit, according to the company, is a multi-product oral dosage form facility for non-cephalosporins and non-beta-lactams.