483
Takasago International CorporationTakasago International Corporation – FDA 483, Nov 19, 2018
Record Details
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.
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ID · 360748f9-806a-4b61-8682-dc0d218d5417
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