483
Baxalta Belgium Manufacturing SAFDA 483 - Baxalta Belgium Manufacturing SA - November 22, 2024
Record Details
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.
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ID · 6605c825-fc8a-48a9-adec-e289950a147a