Meiji Seika Pharma Co., Ltd. - Gifu PlantSeptember 2, 2022

FDA 483 - Meiji Seika Pharma Co., Ltd. - Gifu Plant - September 02, 2022

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Record Details

Meiji Seika Pharma Co., Ltd. in Gifu, an API manufacturer, was cited with three observations during an FDA inspection. The inspection revealed issues with the independence of the quality unit, inadequate controls over computerized label printing systems, and poor facility maintenance including water damage and mold in a raw material warehouse. These findings indicate significant deficiencies in quality systems and facility controls.

Company: Meiji Seika Pharma Co., Ltd. - Gifu Plant
Inspection Date: September 2, 2022
Product Type: Drugs
Office: Office of Biological Products Operations - Division I
Person: Santiago Gallardo Johnson (https://www.fda.gov/media/120628/download)

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ID · 1849aa35-9188-4b4c-b3ae-fd16d72b4371