# FDA 483 - Roslin Cell Therapies Limited - January 21, 2025

Source: https://www.globalkeysolutions.net/records/483/roslin-cell-therapies-limited/0bf97933-396f-4abf-9880-4c5402d1c3b1

> FDA 483 for Roslin Cell Therapies Limited on January 21, 2025. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Roslin Cell Therapies Limited
- Inspection Date: 2025-01-21
- Product Type: biologics
- Office Name: Office of Inspections and Investigations
- Summary: An FDA inspection of ROSLIN CELL THERAPIES LIMITED in Edinburgh revealed significant deficiencies across multiple areas. Observations included inadequate aseptic gowning during sterile drug product manufacturing, lack of access controls and audit trails for electronic production data, and failures within the quality control unit regarding deviation closure and training documentation. These issues indicate a lack of adherence to GMP requirements for sterile drug production and data integrity.

## Related Documents

- [483 - 2023-08-04](https://www.globalkeysolutions.net/records/483/roslin-cell-therapies-limited/98c0b24e-45f9-407d-8ae8-f8de68b67de2)

## Related Officers

- [Peng Zhou](https://www.globalkeysolutions.net/people/peng-zhou/ce413ab5-8787-4012-bc8f-9ef55f2c3dc1)
- [investigator](https://www.globalkeysolutions.net/people/susan-m-jackson/2a4e01d1-8761-4d40-b493-69a4163473bb)

Company: https://www.globalkeysolutions.net/companies/roslin-cell-therapies-limited/284a8034-03ae-4031-906d-7603e297f7ab

Office: https://www.globalkeysolutions.net/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8