FDA 483 - Binex Ltd. - June 20, 2024

The FDA conducted an inspection of Binex Ltd., a drug substance manufacturer located in Incheon, Republic of Korea, from June 12 to June 20, 2024. The inspection revealed significant deficiencies primarily related to contamination control, data integrity, laboratory operations, and quality unit responsibilities, indicating non-compliance with current Good Manufacturing Practices (cGMP).

Key violations included a lack of robust controls to prevent product contamination. Investigators noted inadequate root cause analyses for microbial deviations, ineffective corrective actions, and a failure to properly assess the risk of objectionable microorganisms. Cleaning procedures were found deficient, lacking comprehensive sampling, and disinfectant efficacy studies contained inappropriate conclusions despite failing acceptance criteria. The firm also lacked proper procedures and risk assessments for introducing new products, including health-based exposure limits.

Data integrity issues were identified with electronic systems, including incorrect system dates due to periodic manual changes and multiple instances of SCADA system data loss stemming from aging hardware, without adequate risk assessment. Laboratory controls were deemed insufficient, with recurring endotoxin test failures, incomplete testing procedures, untraceable records, poor sample tracking using erasable markers, and a lack of contemporaneous documentation for analytical tests.

Furthermore, the Quality Unit exhibited deficiencies in record management, incomplete training records, and a lack of equipment identification in the QC laboratory. The firm failed to establish and follow proper procedures for sample transfer and acquisition within the lab.

Binex Ltd. is required to investigate these observations thoroughly, implement comprehensive corrective and preventive actions, and ensure all manufacturing, quality control, and data management systems comply with regulatory standards to prevent recurrence and assure product quality and safety.