# FDA 483 - EUGIA Pharma Specialities Limited - November 14, 2025

Source: https://www.globalkeysolutions.net/records/483/eugia-pharma-specialities-limited/75751173-cc77-4148-9d2c-be0ba4dbebec

> FDA 483 for EUGIA Pharma Specialities Limited on November 14, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: EUGIA Pharma Specialities Limited
- Inspection Date: 2025-11-14
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: An FDA inspection of EUGIA Pharma Specialities Limited in Bhiwadi, India, revealed critical deficiencies in aseptic processing and quality control for sterile drug products. The firm failed to adequately monitor critical interventions, follow aseptic procedures, validate aseptic processes, and maintain an effective environmental monitoring program. These findings indicate a significant risk to the sterility assurance of their manufactured products.

## Related Documents

- [483 - 2018-03-06](https://www.globalkeysolutions.net/records/483/eugia-pharma-specialities-limited/d9cb86c0-e5ad-44af-927a-41fd164955d9)
- [483 - 2024-05-03](https://www.globalkeysolutions.net/records/483/eugia-pharma-specialities-limited/2100530d-b507-419b-8d24-6840d66f73b3)
- [483 - 2024-05-03](https://www.globalkeysolutions.net/records/483/eugia-pharma-specialities-limited/6fcb373a-04fe-4be3-b567-fac453141ee3)

## Related Officers

- [Consumer Safety Officer/ Federal Investigator](https://www.globalkeysolutions.net/people/lisa-l-flores/465a6807-55d7-4c3f-a415-c21ac4517bc9)
- [Quality System Specialist](https://www.globalkeysolutions.net/people/jose-e-melendez/75bd6083-14a4-4bd2-a0e5-9946d4dd37e1)
- [Angelica M. Hernandez](https://www.globalkeysolutions.net/people/angelica-m-hernandez/d66d920c-01b6-4770-a1b5-cac9a1790a0e)

Company: https://www.globalkeysolutions.net/companies/eugia-pharma-specialities-limited/c9c73721-7ca2-4457-89c9-f1001123e141

Office: https://www.globalkeysolutions.net/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8