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 studies that did not meet predefined acceptance criteria. Specifically, environmental monitoring performance qualification studies and a study of washers were found to have failed their acceptance criteria without being repeated. This indicates potential issues with quality control and validation processes at the facility.
- Company
- Baxalta US Incorporated
- Product Type
- Biologics
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ID · 5a11597d-16c5-488c-a489-0a2229cf58f3