# FDA 483 - Baxter Oncology GmbH - August 20, 2018

Source: https://www.globalkeysolutions.net/records/483/baxter-oncology-gmbh/44a76868-527b-4e97-8b39-bf984e859eb6

> FDA 483 for Baxter Oncology GmbH on August 20, 2018. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Baxter Oncology GmbH
- Inspection Date: 2018-08-20
- Product Type: drugs
- Office Name: International Compliance Team
- Summary: Baxter Oncology GmbH received a Form 483 with four observations related to manufacturing process control and quality systems. The firm's process validation was found deficient, leading to commercial lots failing specifications, and critical manufacturing equipment was not properly qualified. Additionally, batch production records lacked necessary documentation, and the quality control unit failed to adhere to its stability monitoring program.

## Related Documents

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## Related Officers

- [Luis M. Burgos](https://www.globalkeysolutions.net/people/luis-m-burgos/0fd6ed19-ed70-474b-86eb-f54fa7f7d1a0)
- [Regulatory Counsel, CDER Compliance, Office of Manufacturing Quality](https://www.globalkeysolutions.net/people/emilie-e-kahn/fac179e5-478f-4e75-9632-40d921f44a8f)

Company: https://www.globalkeysolutions.net/companies/baxter-oncology-gmbh/43dd5bdb-ca73-4678-ba1f-6ef4b5400e06

Office: https://www.globalkeysolutions.net/offices/international-compliance-team/f0ce0d89-bf39-46c6-8c42-28138d161321