# FDA 483 - OrBion Pharmaceuticals Private Limited - September 08, 2023

Source: https://www.keypedia.com/records/483/orbion-pharmaceuticals-private-limited/b5f7d05a-7dad-40db-95aa-7bec1c6cb422

> FDA 483 for OrBion Pharmaceuticals Private Limited on September 08, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: OrBion Pharmaceuticals Private Limited
- Inspection Date: 2023-09-08
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: During an inspection, Orbion Pharmaceuticals Private Limited in Sriperumbudur, India, was cited for three significant observations. These included failures in establishing adequate production and process controls, issues with equipment design and use, and non-adherence to established laboratory control mechanisms. The findings indicate deficiencies in ensuring drug product quality and manufacturing integrity.

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## Related Officers

- [Investigator ](https://www.keypedia.com/people/nicole-e-knowlton/8e65400f-249f-45fe-96fc-cb00fec6ae39)
- [Lillian S. Wu](https://www.keypedia.com/people/lillian-s-wu/b1f6643c-ac01-43e5-8ce2-e6f4fdba9d35)

Company: https://www.keypedia.com/companies/orbion-pharmaceuticals-private-limited/1cdc049d-587c-4283-8d5c-8604cff032c9

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