FDA 483 - International Chemical Entity Japan Co., Ltd. - September 05, 2025

An FDA inspection of International Chemical Entity Japan Co., Ltd., an API manufacturer in Iwaki, Fukushima, Japan, revealed two significant observations. The firm failed to establish scientifically sound procedures for identifying microorganisms in environmental and water samples and did not use validated, stability-indicating test procedures, specifically omitting forced degradation studies. These deficiencies undermine product quality assurance and patient safety.