# FDA 483 - Eugia Pharma Specialities Limited - December 14, 2018

Source: https://www.globalkeysolutions.net/records/483/eugia-pharma-specialities-limited/ba5f5ab2-9af9-4614-9470-b9b649b27bed

> FDA 483 for Eugia Pharma Specialities Limited on December 14, 2018. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Eugia Pharma Specialities Limited
- Inspection Date: 2018-12-14
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Aurobindo Pharma Limited - Unit IV in Hyderabad, India, revealed significant deficiencies in aseptic processing. The firm failed to establish and follow adequate procedures to prevent microbiological contamination of sterile drug products, with issues noted in environmental monitoring, smoke studies, and media fill simulations. Additionally, protective apparel was not consistently worn to protect drug products from contamination.

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## Related Officers

- [Jose A. Cruz Gonzalez](https://www.globalkeysolutions.net/people/jose-a-cruz-gonzalez/a005cff1-0a90-4396-82c4-de4b0a579374)

Company: https://www.globalkeysolutions.net/companies/eugia-pharma-specialities-limited/9733456f-3189-4fe6-a4f9-327f0ce92559

Office: https://www.globalkeysolutions.net/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1