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

Source: https://www.keypedia.com/records/483/baxalta-belgium-manufacturing-sa/675a7f46-8637-422d-834e-98f80bbc5db6

> 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: Baltimore District Office
- Summary: During an FDA inspection conducted from November 14 to November 22, 2024, at Baxalta Belgium Manufacturing SA, several deficiencies were observed in their manufacturing operations. The primary issues identified related to the company's batch production and control records. Specifically, the inspection noted that essential information regarding major equipment used in manufacturing was absent from batch records. For instance, critical filling parameters and controls for products such as GAMMAGARD Liquid® and Cuvitru® were not adequately documented. This lack of detailed equipment identity in batch records indicates a gap in their control procedures.

Furthermore, the inspection revealed that alarms, particularly those related to filling parameters generated during the manufacturing of products like Glassia®, were not consistently reviewed or evaluated during batch record assessments. This suggests an inadequacy in addressing process deviations or potential issues captured by automated systems. These observations, issued on an FDA Form 483, indicate practices that may not comply with the Federal Food, Drug, and Cosmetic Act. Baxalta Belgium Manufacturing SA is expected to respond to these observations by outlining corrective actions implemented or planned to ensure complete and accurate batch record documentation and thorough evaluation of all process alarms.

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

Office: https://www.keypedia.com/offices/baltimore-district-office/6be371ff-03e9-4039-999c-ff170f17a9fa