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# Eugia Sent 7-Item 483 After India Inspection
- URL: https://www.fdaweb.com/eugia-sent-7-item-483-after-india-inspection/
- Published: 2024-05-13T12:00:00.000Z
- Updated: 2026-09-14T14:30:38.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5156968

FDA has issued Eugia Pharma Specialties (an Aurobindo subsidiary) a seven-item [Form-483](https://www.fda.gov/media/178585/download?attachment&ref=fdaweb.com) following a 5/3-concluded inspection at its sterile drug manufacturing facility in Rajasthan, India. The agency says the company’s procedures designed to prevent microbiological contamination of drug products are not followed, and they do not include adequate validation of the aseptic process. The inspection also cited the firm over its failure to thoroughly review any unexplained discrepancy. Additionally, FDA said Eugia failed to establish adequate written procedures for production and process controls that are designed to assure that the drug products have the identity, strength, purity, and quality that they are purported or represented to possess.