FDA 483 - Suzhou Union Biopharm Co., Ltd. - May 26, 2023

During an inspection from May 15 to May 26, 2023, the U.S. Food and Drug Administration (FDA) issued a Form 483 to Suzhou Union Biopharma Co. Ltd., a drug substance and drug product manufacturer in China. The observations highlighted significant deficiencies in the company's adherence to Good Manufacturing Practices (GMP). Key violations included inadequate procedures to prevent microbiological contamination during aseptic processing of sterile drug products. Inspectors noted improper sanitization practices for equipment (Restricted Access Barriers), incorrect handling of sterilized components, direct contact with critical sterile areas, and suboptimal operator practices during aseptic setup and filling. Furthermore, the quality unit's oversight was found deficient, exemplified by a delayed discovery of a cleaning equipment malfunction that impacted multiple drug product batches, including a U.S. clinical lot, without appropriate subsequent validation. The FDA also cited inadequate or unenforced written procedures regarding batch record keeping (unsecured loose-leaf records), insufficient detail for trending in annual product quality reviews, incomplete reference standard requalification, and inappropriate timelines for stability studies. Suzhou Union Biopharma Co. Ltd. is required to address these inspectional observations by implementing comprehensive corrective actions and submitting a detailed response to the FDA.