# FDA 483 - EUGIA Pharma Specialities Limited - August 28, 2019

Source: https://www.globalkeysolutions.net/records/483/eugia-pharma-specialities-limited/8722eaf2-072f-4019-b613-fbfdbdade1d9

> FDA 483 for EUGIA Pharma Specialities Limited on August 28, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: EUGIA Pharma Specialities Limited
- Inspection Date: 2019-08-28
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: EUGIA Pharma Specialities Limited, a human drug manufacturer in Medchal, India, was cited for significant deficiencies in its quality control unit, laboratory controls, and sample management. The inspection revealed issues with timely batch record review, inadequate stability studies for drug products, and insufficient identification and logging of various samples. These observations indicate a need for improved adherence to established procedures and scientific justification in their manufacturing and testing processes.

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## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/roger-f-zabinski/87e05838-f8b5-489a-8db7-6669e68a2c2e)

Company: https://www.globalkeysolutions.net/companies/eugia-pharma-specialities-limited/7c9f680c-5d29-42a0-a496-02fd4761792b

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