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# CGMP Issues Cited in Takeda Inspection
- URL: https://www.fdaweb.com/cgmp-issues-cited-in-takeda-inspection/
- Published: 2020-06-16T12:00:00.000Z
- Updated: 2026-09-14T16:18:17.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5147022

An FDA 11/18-11/26/19 inspection at Takeda 4720, Yamaguchi, Japan, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. A 6/9 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/takeda-pharmaceutical-company-limited-603596-06092020?ref=fdaweb.com) says specific violations were: 

- failing to establish adequate written responsibilities and procedures applicable to the quality control unit and to follow such written procedures;
- failing to establish and follow appropriate written procedures designed to prevent microbiological contamination of drug products purporting to be sterile, including validation of all aseptic and sterilization processes; and
- failing to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether the batch has already been distributed.

Takeda was told to respond with a list of specific actions taken since the inspection to correct the violations and prevent their recurrence, with a schedule for completing the actions.