# FDA 483 - Curia India Private Limited - February 16, 2024

Source: https://www.globalkeysolutions.net/records/483/curia-india-private-limited/94ab7e37-94d3-483f-bec0-12a5e45429e3

> FDA 483 for Curia India Private Limited on February 16, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Curia India Private Limited
- Inspection Date: 2024-02-16
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Curia India Pvt. Ltd. in Aurangabad, India, identified deficiencies in the firm's laboratory methods and procedures. The inspection revealed issues with the preparation of secondary reference standards, outdated written procedures for primary standard procurement, and a lack of scientific justification for retesting during out-of-specification investigations. These findings indicate a need for improved quality control in laboratory operations.

## Related Officers

- [Youkeun Kim](https://www.globalkeysolutions.net/people/youkeun-kim/94ccfde4-72f7-4df1-9c68-ede73e5e23d0)

Company: https://www.globalkeysolutions.net/companies/curia-india-private-limited/957a813a-fe8f-4ea0-92bb-b16a25119979

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