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

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

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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)

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