FDA 483 - SUNJIN BEAUTY SCIENCE CO., LTD - August 01, 2025
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An FDA inspection of SUNIN BEAUTY SCIENCE CO., LTD in Seocheon County, Korea, identified significant deficiencies across multiple quality systems. The firm failed to adequately investigate contamination and out-of-specification events, lacked stability data to support product retest dates, and demonstrated inadequate validation for both a critical production system and cleaning procedures. These issues raise concerns about the quality control of drug products distributed to the US market.
ID · 176e5dc0-dece-4dee-9fe6-846a460e3ea2