# FDA 483 - ANTHEM BIOSCIENCES PRIVATE LIMITED - Phase II - December 08, 2022

Source: https://www.globalkeysolutions.net/records/483/anthem-biosciences-private-limited-phase-ii/ae9a8d39-7988-4a6f-8895-13153343060d

> FDA 483 for ANTHEM BIOSCIENCES PRIVATE LIMITED - Phase II on December 08, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: ANTHEM BIOSCIENCES PRIVATE LIMITED - Phase II
- Inspection Date: 2022-12-08
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Anthem Biosciences Private Limited in Ramnagar, Karnataka, was cited for significant deficiencies in its quality systems, facilities, and production controls during an FDA inspection. The inspection revealed inadequate investigations into failures, poor water system control, lack of quality unit oversight for supplier qualification, and insufficient cleaning validation for manufacturing equipment. Additionally, the facility's cleanrooms were not adequately maintained, and process validation for drug substance manufacturing was found to be deficient.

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/kellia-n-hicks/44104c4a-70c1-47fc-9a77-c09c41bacc2b)

Company: https://www.globalkeysolutions.net/companies/anthem-biosciences-private-limited-phase-ii/df5d2c40-b402-492b-9369-42c7f15f0a08

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