FDA 483 - Oxford Biomedica (UK) Limited - February 11, 2019

Oxford Biomedica Ltd. in Oxford, UK, was cited for significant deficiencies in its quality system related to deviation management and investigations. The firm failed to thoroughly investigate unexplained discrepancies and out-of-specification results, lacking complete root cause analyses and timely corrective actions. Additionally, deviation forms did not consistently include opening dates, hindering the assessment of timely closure for various deviation types.