> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Eugia Pharma Specialties FDA-483 Out
- URL: https://www.fdaweb.com/eugia-pharma-specialties-fda-483-out/
- Published: 2026-04-30T12:00:00.000Z
- Updated: 2026-09-14T13:38:26.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5161069

FDA has released the form [FDA-483](https://www.fda.gov/media/192210/download?ref=fdaweb.com) issued following a 2/16-2/27 inspection at Eugia Pharma Specialties Limited, a Telangana, India, sterile pharmaceutical manufacturer. Inspection observations included:

- failure to establish and follow procedures designed to prevent microbiological contamination of drug products purporting to be sterile;
- failure of procedures designed to prevent microbiological contamination of drug products purporting to be sterile to include adequate validation of the aseptic process; and
- failure of laboratory controls to include the establishment of scientifically sound and appropriate test procedures designed to assure that drug products conform to appropriate standards of identity, strength, quality, and purity.