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# 3rd Eugia FDA-483 This Year So Far
- URL: https://www.fdaweb.com/3rd-eugia-fda-483-this-year-so-far/
- Published: 2024-04-17T12:00:00.000Z
- Updated: 2026-09-14T14:28:34.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5156792

FDA has released the form [FDA-483](https://www.fda.gov/media/177845/download?attachment&ref=fdaweb.com) issued following a 3/28-4/5 inspection at the Eugia Steriles Private Limited drug manufacturing facility in Andhra, Pradesh, India. It was the third form FDA-483 issued to a Eugia facility in 2024 so far.

The three inspection observations on the latest form were:

- failure to establish and follow procedures to prevent microbiological contamination of drug products purporting to be sterile;
- failure to check input to and output from the computer and records or data for accuracy; and
- failing to establish control procedures that validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product.

A February inspection at the firm’s sterile drug manufacturing facility in Telangana, India, drew a form [FDA-483](https://www.fdaweb.com/eugia-inspection-results-in-7-item-fda-483/) with seven observations. There were nine observations on a 26-page form [FDA-483](https://www.fdaweb.com/9-observations-in-eugia-pharma-inspection/) issued following a January inspection at the firm’s sterile drug manufacturing facility in Sangareddy, Telangana, India.