TERUMO YAMAGUCHI CORPORATIONMarch 30, 2023

FDA 483 - TERUMO YAMAGUCHI CORPORATION - March 30, 2023

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TERUMO YAMAGUCHI CORPORATION, a sterile drug manufacturer in Yamaguchi, Japan, was cited with two observations during an FDA inspection. The inspection revealed deficiencies related to the sampling and testing of components for sterile drug products and issues with data integrity, specifically concerning the security and completeness of backup data for analytical equipment.

Company: TERUMO YAMAGUCHI CORPORATION
Inspection Date: March 30, 2023
Product Type: Drugs
Office: Office of Biological Products Operations - Division I
People: Marcellinus D. Dordunoo (Investigator)
Melanie W. Pishnery

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ID · d47937e0-182b-47e6-a192-af22f0393f7f