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

Source: https://www.keypedia.com/records/483/roslin-cell-therapies-limited/98c0b24e-45f9-407d-8ae8-f8de68b67de2

> FDA 483 for Roslin Cell Therapies Limited on August 04, 2023. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Roslin Cell Therapies Limited
- Inspection Date: 2023-08-04
- Product Type: biologics
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: 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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Company: https://www.keypedia.com/companies/roslin-cell-therapies-limited/284a8034-03ae-4031-906d-7603e297f7ab

Office: https://www.keypedia.com/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd