483
Binex Co., LtdFDA 483 - Binex Co., Ltd - June 20, 2024
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Binex Ltd., a drug substance manufacturer in Incheon, Republic of Korea, was cited for significant deficiencies across its operations. The inspection revealed a lack of contamination prevention, inadequate data integrity controls for electronic systems, and widespread issues with laboratory controls. Furthermore, the Quality Unit's responsibilities and procedures were found to be insufficient, impacting record management and training.
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