FDA 483 - Shiseido America Inc. - December 03, 2024

An FDA inspection conducted at Shiseido America Inc. from November 25 to December 3, 2024, identified significant quality control and storage practice concerns. The inspection revealed two primary observations. First, the firm lacked a robust program for routine equipment calibration and qualification. Specifically, essential equipment used in ongoing long-term stability studies for drug products like sunscreens, and an instrument for raw material water content analysis, lacked proper qualification data and consistent routine calibration. This deficiency raises concerns about the accuracy and reliability of manufacturing and testing processes. Second, drug products and their raw materials were not stored under appropriate temperature conditions. The firm failed to conduct comprehensive temperature mapping studies for its raw material warehouse, nor did it provide scientific justification for the current temperature monitoring locations to ensure they represented worst-case storage scenarios. These observations, issued under Section 704(b) of the Federal Food, Drug and Cosmetic Act, highlight deviations from expected Good Manufacturing Practices. Shiseido America Inc. is expected to promptly address these findings by implementing comprehensive corrective actions and submitting a detailed response to the FDA to ensure regulatory compliance and uphold product quality and integrity.