# FDA 483 - Nippon Shikizai, Inc. - August 06, 2019

Source: https://www.globalkeysolutions.net/records/483/nippon-shikizai-inc/0040da34-6484-4aaa-bf62-b5462515b407

> FDA 483 for Nippon Shikizai, Inc. on August 06, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Nippon Shikizai, Inc.
- Inspection Date: 2019-08-06
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: 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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## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/sarah-e-rhoades/d965990c-15cc-4722-b2d0-aea7206c71b0)

Company: https://www.globalkeysolutions.net/companies/nippon-shikizai-inc/252cb221-d383-4603-b0ec-18e8cac34e32

Office: https://www.globalkeysolutions.net/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1