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# Aurobindo’s Eugia Pharma Unit Cited After FDA Inspection
- URL: https://www.fdaweb.com/aurobindos-eugia-pharma-unit-cited-after-fda-inspection/
- Published: 2026-02-09T12:00:00.000Z
- Updated: 2026-09-14T15:32:54.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5160627

Aurobindo Pharma is reporting that FDA has completed an inspection of wholly owned subsidiary Eugia Pharma Specialities in Pashamylaram, Telangana, India that resulted in 11 procedural observations. The inspection focused on Unit III, Eugia’s formulations manufacturing facility, from 1/27 to 2/6.

The latest inspection comes on the heels of several recent FDA examinations of Eugia Pharma facilities. In 11/2025, [FDA inspected](https://www.aurobindo.com/api/uploads/disclosureofeventsinformation/LtrToSEsUNit2EugiaFDA14112025.pdf?utm%5Fsource=chatgpt.com) a formulations facility (Unit II) in Bhiwadi, Rajasthan, India, which resulted in nine procedural observations.

A 1/22-2/2/2024 FDA inspection at Eugia Pharma Specialties’ drug manufacturing facility in Hyderabad, Telangana, India, identified significant GMP violations for finished drugs. The inspection resulted in an 8/2024 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/eugia-pharma-specialities-limited-681905-08152024?ref=fdaweb.com). Specific violations were:

- failure to ensure that laboratory records included complete data derived from all tests necessary to ensure compliance with established specifications and standards;
- failure to prepare batch production and control records with complete information relating to the production and control of each batch of drug product produced;
- failure to establish and follow appropriate written procedures designed to prevent microbiological contamination of drug products purporting to be sterile, including validation of all aseptic and sterilization processes; and
- failure to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed.

Aurobindo Pharma has emphasized in its filings that the observations in most recent inspections have been procedural in nature and that the company is committed to maintaining high quality and compliance standards across its global operations.