# FDA 483 - Baxalta Belgium Manufacturing SA - November 22, 2024

Source: https://www.globalkeysolutions.net/records/483/baxalta-belgium-manufacturing-sa/6605c825-fc8a-48a9-adec-e289950a147a

> FDA 483 for Baxalta Belgium Manufacturing SA on November 22, 2024. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Baxalta Belgium Manufacturing SA
- Inspection Date: 2024-11-22
- Product Type: biologics
- Office Name: Office of Inspections and Investigations
- Summary: Baxalta Belgium Manufacturing SA, a plasma derivative manufacturer in Lessines, Belgium, was cited for deficiencies in its batch production and control records. The inspection revealed that major equipment identity was not documented in batch records, and alarms generated during filling processes were not consistently reviewed or evaluated. These issues indicate a lack of adequate control over manufacturing processes and record-keeping.

## Related Documents

- [483 - 2019-05-20](https://www.globalkeysolutions.net/records/483/baxalta-belgium-manufacturing-sa/6dbcde81-2291-4b42-a556-6dc3897f5b55)
- [483 - 2024-11-22](https://www.globalkeysolutions.net/records/483/baxalta-belgium-manufacturing-sa/d58d9b78-e7e5-42a0-b2c8-6d8a4357eb4f)

## Related Officers

- [Alan L. Truong](https://www.globalkeysolutions.net/people/alan-l-truong/8b9c59ed-ce68-44c3-9fbe-07cc3da13713)
- [issuing_officer](https://www.globalkeysolutions.net/people/malgorzata-g-norton/ba7b8827-0976-4abd-8abb-95d4222d2bdc)
- [Investigator](https://www.globalkeysolutions.net/people/shafiq-s-ahadi/dd146b0a-ca1c-4052-8f50-4d68e14ad73f)

Company: https://www.globalkeysolutions.net/companies/baxalta-belgium-manufacturing-sa/61b3acce-a147-4f22-b13a-34bb436ea8e9

Office: https://www.globalkeysolutions.net/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8