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

An FDA Form 483 was issued to Roslin Cell Therapies, Ltd. following an inspection conducted from July 31, 2023, to August 4, 2023, at their manufacturing facility in Edinburgh, United Kingdom. The inspection, carried out under the authority of the Federal Food, Drug, and Cosmetic Act, identified two significant observations concerning the company's manufacturing and quality control processes. Firstly, the inspection revealed inadequate qualification of equipment, specifically biosafety cabinets in designated clean rooms, which lacked sufficient demonstration of appropriate internal airflow during critical manufacturing operations. Secondly, deficiencies were noted in the visual inspection process qualification. The defect challenge sets used for training and qualifying inspectors were found to be unrepresentative of the final filled drug product vials, particularly regarding solution clarity and vial type. Roslin Cell Therapies is required to address these observations, typically by developing and implementing corrective actions to resolve the identified issues and ensure compliance with regulatory standards, which is critical for product quality and patient safety.