483
Roslin Cell Therapies LimitedFDA 483 - Roslin Cell Therapies Limited - August 04, 2023
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An FDA inspection of Roslin Cell Therapies, Ltd. in Edinburgh, United Kingdom, identified two significant issues related to manufacturing quality. The firm was cited for inadequate qualification of biosafety cabinets, failing to demonstrate proper airflow, and for deficiencies in its visual inspection process qualification, specifically regarding unrepresentative defect challenge sets.
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ID · 98c0b24e-45f9-407d-8ae8-f8de68b67de2