FDA 483 - Yuki Gosei Kogyo Co., Ltd. - February 02, 2026

Yuki Gosei Kogyo, Co., Ltd. in Iwaki-shi, Japan, an API manufacturer, received a Form 483 citing significant deficiencies in quality systems. Observations included inadequate and untimely complaint investigations, a lack of procedures for testing objectionable microorganisms in water used for API production, and deficient supplier qualification practices. These issues indicate a moderate level of severity, impacting product quality and patient safety.