FDA 483 - Binex Ltd. - June 20, 2024

The FDA inspected Binex Ltd., a drug substance manufacturer located in Incheon, Republic of Korea, from June 12-20, 2024. The inspection revealed significant violations of Good Manufacturing Practices, primarily concerning contamination control, data integrity, and laboratory oversight.

Key issues included a lack of assurance in manufacturing operations to prevent contamination, evidenced by inadequate root cause analyses for microbial deviations, recurring contamination (including *B. cepacia* leading to batch terminations and inappropriate product release), and insufficient disinfectant efficacy studies. Cleaning validation for multi-use equipment was deemed inadequate, and new product introductions lacked proper procedures and comprehensive risk assessments, including health-based exposure limits.

Data integrity concerns were raised due to inappropriate management of electronic system dates and multiple data losses from the SCADA system without adequate risk assessment. Laboratory controls were deficient, with recurring endotoxin test failures not receiving robust corrective actions, incomplete written procedures, deficient sample tracking, and a lack of contemporaneous data recording in the LIMS system.

Furthermore, the Quality Unit exhibited deficiencies in controlled recordkeeping, incomplete employee training records, unidentified laboratory equipment, and informal sample transfer processes. Binex Ltd. is required to implement comprehensive corrective and preventive actions to address these systemic issues and ensure compliance with regulatory standards for drug substance quality and safety.