FDA 483 - International Chemical Entity Japan Co., Ltd. - March 18, 2019

An FDA inspection of API Corporation, an API manufacturer in Iwaki, Fukushima, Japan, revealed significant deficiencies in their laboratory controls. The firm failed to establish scientifically sound specifications and test procedures, leading to issues like unvalidated methods and unsecured analytical equipment. Additionally, the inspection found that complete electronic raw data from critical laboratory tests were not being maintained.