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# Takeda Slapped with 4-Item FDA-483
- URL: https://www.fdaweb.com/takeda-slapped-with-4-item-fda-483/
- Published: 2024-11-18T12:00:00.000Z
- Updated: 2026-09-14T14:47:20.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5158207

DA is has issued Takeda Pharmaceutical a four-item [Form FDA-483](https://www.fda.gov/media/183580/download?ref=fdaweb.com) after inspecting the firm’s Yamaguchi, Japan manufacturing facility. Agency investigators found that the facility’s investigations into unexplained discrepancies did not result in written records being created. They also cited Takeda for failing to thoroughly review any unexplained discrepancy or the failure of a batch or any of its components to meet any of its specifications.

The inspection also took issue with the facility’s aseptic processing areas because they are “deficient regarding the system for monitoring environmental conditions.” Additionally, the inspection form said each batch of drug product required to be free of objectionable microorganisms is not assessed in appropriate laboratory testing.