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483
•Ajinomoto Co. Inc (Kyushu Plant)•July 14, 2025

Ajinomoto Co. Inc (Kyushu Plant) – FDA 483, Jul 14, 2025

Record Details

The FDA inspected Ajinomoto Co. Inc. Kyushu Plant, an API manufacturer in Saga, Japan, and found a significant failure to thoroughly review unexplained discrepancies. Deviation reports lacked scientific rationale, root cause analysis, and sufficient QA oversight, raising concerns about the quality and purity of their APIs.

Company
Ajinomoto Co. Inc (Kyushu Plant)
Inspection date
July 14, 2025
Product type
drugs
Office
Office of Biological Products Operations - Division I
Person
  • Marian E. Ramirez (investigator)
View Company Profile

ID · f92a6448-8bc1-4731-bcb2-b0c7f106d1d3

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