483
Baxalta US IncorporatedFDA 483 - Baxalta US Incorporated
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Record Details
An FDA inspection of Baxalta US Inc. in Los Angeles, CA, a blood fractionation manufacturing facility, identified two observations related to quality control. The firm failed to repeat environmental monitoring performance qualification studies and a washer study, despite these studies not meeting their predefined acceptance criteria. This indicates a deficiency in ensuring the validity and reliability of critical manufacturing processes.
- Company
- Baxalta US Incorporated
- Product Type
- Biologics
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ID · 2c9f53ea-4178-44bd-9dff-97e8db87c69b