483
SK Biotek Co., Ltd. (Sejong Plant)FDA 483 - SK Biotek Co., Ltd. (Sejong Plant) - June 10, 2026
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An FDA inspection of SK Biotek Co., Ltd.'s Sejong Plant, an API manufacturer, revealed two significant observations. The firm lacked adequate scientific justification for its reduced microbial enumeration testing program for API batches. Additionally, established hold times for raw materials, intermediates, and finished APIs were not properly documented and verified in batch records.
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ID · 682aacdb-d865-421f-9fb4-42316bd9d06f