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

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.