FDA 483 - BrightGene BioMedical Technology Co., Ltd. - August 10, 2023

An FDA inspection of BrightGene Bio-Medical Technology Co., Ltd. in Suzhou, China, revealed significant deficiencies within its quality control unit. The firm failed to adhere to established procedures, including a lack of raw data for vendor calibrations, incomplete data review forms for released batches, and inadequate investigations into system suitability failures and audit trail issues. These observations indicate a systemic breakdown in maintaining proper quality oversight and data integrity.