FDA 483 - Takasago International Corporation - November 19, 2018

Takasago International Corporation in Iwata, Japan, an API intermediates manufacturer, was inspected by the FDA from November 19-22, 2018. The inspection revealed a significant deficiency in the firm's quality system, specifically regarding the lack of adequate written procedures for out-of-specification investigations. This procedural gap led to an ongoing stability failure investigation being handled informally without proper documentation or tracking.