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# 10-Page Eugia Steriles FDA-483
- URL: https://www.fdaweb.com/10-page-eugia-steriles-fda-483/
- Published: 2026-10-27T20:19:15.000Z
- Updated: 2026-10-27T20:19:15.000Z
- Author: David McFarland
- Tags: enforcement

FDA has released the 10-page Form FDA-483 issued following a 6/10-6/19 inspection at the Eugia Steriles Private Limited sterile drug product manufacturing facility in Andhra Pradesh, India. The five inspection observations were:

- failure to establish and follow written procedures designed to prevent microbiological contamination of drug products purporting to be sterile;
- failure to ensure that procedures designed to prevent microbiological contamination of drug products purporting to be sterile include adequate validation of the aseptic process;
- failure to have in writing and fully follow the responsibilities and procedures applicable to the quality control unit;
- failure of written records of investigations into unexplained discrepancies to always include the conclusions and follow-up; and
- failure to establish the reproducibility of test methods.