# FDA 483 - Eugia SEZ Private Limited - May 04, 2018

Source: https://www.globalkeysolutions.net/records/483/eugia-sez-private-limited/9d6255cf-d0c7-42ab-8453-18416bd4cf5b

> FDA 483 for Eugia SEZ Private Limited on May 04, 2018. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Eugia SEZ Private Limited
- Inspection Date: 2018-05-04
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Aurobindo Pharma Limited, an injectable manufacturer in Mahabubnagar District, India, was cited for significant deficiencies during an FDA inspection. Observations included a failure to thoroughly investigate product discrepancies, inadequate cleaning and disinfection procedures in aseptic processing areas, and insufficient employee training for critical operations. These issues indicate a lack of robust quality control and aseptic practices.

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## Related Officers

- [Investigator ](https://www.globalkeysolutions.net/people/marie-buen-bigornia/0d363d83-b630-447d-8766-09c8f85665a7)
- [Consumer Safety Officer/ORA/OMPTO/TOS](https://www.globalkeysolutions.net/people/niketa-patel/73efe456-da61-4345-8dec-7147b12b88d1)

Company: https://www.globalkeysolutions.net/companies/eugia-sez-private-limited/c458dd25-5620-40af-93fe-f25936ff47e8

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