FDA 483 - SUNJIN BEAUTY SCIENCE CO., LTD - August 01, 2025

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.