FDA 483 - Stella Chemifa Corporation - September 22, 2023

Stella Chemifa Corporation, an API manufacturer in Izumiotsu City, Osaka, Japan, was cited for deficiencies during an FDA inspection. The observations primarily concern an inadequate accelerated stability program, including issues with sample container materials and delayed sample analysis. Additionally, the firm failed to ensure scientifically sound test procedures for API analysis, leading to impurity accumulation and affecting product quality and purity.