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

Source: https://www.keypedia.com/records/483/shiseido-america-inc/23a1f412-e7dd-459a-ac79-0079d2be2a30

> FDA 483 for Shiseido America Inc. on December 03, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Shiseido America Inc.
- Inspection Date: 2024-12-03
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: 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.

## Related Documents

- [483 - 2018-11-01](https://www.keypedia.com/records/483/shiseido-america-inc/767a07dc-4b5e-40cc-8cb6-e2d4f34fdd04)

## Related Officers

- [Ankur C. Patel](https://www.keypedia.com/people/ankur-c-patel/602c7d14-2c48-4929-a07b-6e4c235d7f13)

Company: https://www.keypedia.com/companies/shiseido-america-inc/612a919a-3309-4649-b8bf-d8cd6af8ed5a

Office: https://www.keypedia.com/offices/new-jersey-district-office/6ff5e2e9-5cff-44c7-af24-5a55329a8248