# FDA 483 - Eugia SEZ Private Limited - March 01, 2019

Source: https://www.keypedia.com/records/483/eugia-sez-private-limited/d2dfde51-d58c-479f-b72e-13a40c55f344

> FDA 483 for Eugia SEZ Private Limited on March 01, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Eugia SEZ Private Limited
- Inspection Date: 2019-03-01
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Aurobindo Pharma Limited, a manufacturer of sterile drug products in Mahabubnagar District, India, received 11 observations during an FDA inspection. The observations highlight significant deficiencies across quality control, manufacturing process validation, complaint investigations, employee training, environmental monitoring in aseptic areas, and laboratory controls. These issues indicate a lack of robust systems to ensure the quality, sterility, and purity of their drug products.

## Related Documents

- [483 - 2018-05-04](https://www.keypedia.com/records/483/eugia-sez-private-limited/9d6255cf-d0c7-42ab-8453-18416bd4cf5b)
- [483 - 2019-03-01](https://www.keypedia.com/records/483/eugia-sez-private-limited/cb641586-ada5-4f78-bdf8-443b3c625895)
- [483 - 2024-02-29](https://www.keypedia.com/records/483/eugia-sez-private-limited/c9950ab3-3852-4ab3-a977-1234b0111d75)

## Related Officers

- [Chemist/Investigator - Pharmaceutical Quality](https://www.keypedia.com/people/walden-h-lee/18131eea-d1cb-47c4-af79-bea22d436031)
- [company_representative](https://www.keypedia.com/people/jose-mendez/8e429635-0214-429b-b6c5-9f6839d5489b)
- [SVP Consulting & Operations](https://www.keypedia.com/people/linda-f-murphy/a8b9737f-d5f4-4a36-8684-2fb050d008f2)

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

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