FDA 483 - Towa Pharmaceutical Europe, S.L. - September 09, 2022

An FDA inspection of Towa Pharmaceutical Europe, S.L. in Martorelles, Barcelona, Spain, a drug manufacturer, revealed significant deficiencies across its quality systems. Observations included failures in thoroughly reviewing discrepancies related to IT system audit trails and sample set abortions, inadequate complaint handling procedures for adverse events, and insufficient cleaning validation studies. Additionally, the firm's annual product reviews were found to be deficient, not including all relevant batches.