483
Kolmar Korea Co. Ltd.Kolmar Korea Co. Ltd. – FDA 483, Jul 5, 2019
Record Details
Kolmar Korea Co. Ltd., an OTC drug manufacturer in Sejong-si, Korea, received a Form 483 with seven observations during an FDA inspection. The inspection revealed severe deficiencies in quality control unit oversight, data integrity, record-keeping practices, complaint investigations, and employee training. These issues indicate a systemic failure to adhere to cGMP regulations, with several observations being repeats from previous inspections.
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ID · 0c055ad2-35dd-41b2-8097-94af2af70516
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