# FDA 483 - Fresenius Kabi Oncology Limited - October 10, 2023

Source: https://www.globalkeysolutions.net/records/483/fresenius-kabi-oncology-limited/d19a7f12-f3d8-4588-ac33-b115b6673823

> FDA 483 for Fresenius Kabi Oncology Limited on October 10, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Fresenius Kabi Oncology Limited
- Inspection Date: 2023-10-10
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Fresenius Kabi Oncology Limited in Solan, India, revealed significant deficiencies across its sterile injectable drug manufacturing operations. Key issues include widespread failures in aseptic processing practices, falsification of environmental monitoring records, and inadequate validation of critical manufacturing steps. The findings indicate a serious lack of control over processes designed to ensure product sterility and data integrity.

## Related Documents

- [483 - 2023-10-10](https://www.globalkeysolutions.net/records/483/fresenius-kabi-oncology-limited/fe3c67ce-6ae7-4fec-b346-4bb802c84a55)

## Related Officers

- [Research Specialist II](https://www.globalkeysolutions.net/people/justin-a-boyd/796c9c9d-02db-486c-bdca-cc259066a0e2)
- [Consumer Safety Officer ](https://www.globalkeysolutions.net/people/anastasia-m-shields/a22b8d52-e3f9-4e61-aa3f-6f03ff2f59df)

Company: https://www.globalkeysolutions.net/companies/fresenius-kabi-oncology-limited/d092c98c-aa35-490f-97c4-3ed02fe7dac7

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