483
Shiseido America Inc.FDA 483 - Shiseido America Inc. - December 03, 2024
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An FDA inspection of Shiseido America Inc. in East Windsor, NJ, revealed two significant observations. The firm failed to ensure routine calibration and qualification of equipment used in drug product stability studies and manufacturing. Additionally, the raw material warehouse lacked proper temperature mapping studies and scientific justification for monitoring locations, potentially affecting drug product quality.
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