Roslin Cell Therapies LimitedAugust 4, 2023

FDA 483 - Roslin Cell Therapies Limited - August 04, 2023

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Record Details

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.

Company: Roslin Cell Therapies Limited
Inspection Date: August 4, 2023
Product Type: Biologics
Office: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
People: Gregory Price
Cesar Orlo
Zhaohui Ye
Jessica Chery

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ID · 98c0b24e-45f9-407d-8ae8-f8de68b67de2