FDA 483 - Sumitomo Chemical Co., Ltd. - December 08, 2017

Sumitomo Chemical Co., Ltd. in Anpachi-Gun, Gifu Prefecture, Japan, was cited for significant deficiencies in laboratory controls, analytical method validation, and equipment cleaning during an FDA inspection. The firm failed to apply scientific rationale in testing, properly investigate out-of-specification results, ensure adequate employee training, and maintain equipment free of contaminants. Additionally, issues with computerized system traceability were noted.