483
Nippon Shikizai, Inc.FDA 483 - Nippon Shikizai, Inc. - August 06, 2019
Record Details
An FDA inspection of Nippon Shikizai, Inc. in Tsukuba, Ibaraki, Japan, an OTC drug manufacturer, revealed significant deficiencies. Observations included inadequate cleaning validation for multi-product equipment, insufficient calibration of production scales, and a lack of written procedures for tracking and managing deviations by the quality assurance unit. These issues indicate potential risks to drug product quality and compliance with cGMP regulations.
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ID · 0040da34-6484-4aaa-bf62-b5462515b407