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FirstCham Co., Ltd., a South Korean drug manufacturer, was cited for significant Current Good Manufacturing Practice (CGMP) violations in the production of over-the-counter hand sanitizer products, including the Soo'Ae Hand Sanitizing Wipes. The company failed to conduct adequate identity testing and validation of incoming raw material components, and did not establish reliable supplier test analyses at appropriate intervals as required by 21 CFR 211.84. The firm's November 2023 response to the FDA's Form 483 was determined to be inadequate, lacking sufficient detail or evidence of corrective actions to achieve compliance with CGMP regulations.