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# Eugia Pharma Gets Fourth FDA-483 in 2024
- URL: https://www.fdaweb.com/eugia-pharma-gets-fourth-fda-483-in-2024/
- Published: 2024-05-03T12:00:00.000Z
- Updated: 2026-09-14T14:29:58.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5156913

A Eugia Pharma Specialities (an Aurobindo subsidiary) formulation manufacturing facility in Rajasthan, India has been issued a seven-observation FDA Form-483 after being inspected by the agency from 4/25 to 5/3\. “The observations are procedural in nature and will be responded to within the stipulated time,” the company said in a financial statement.

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