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

Source: https://www.globalkeysolutions.net/records/483/nippon-shikizai-inc/9fc95dcf-e505-4f0c-a304-dfffafd36d26

> 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: Center for Veterinary Medicine
- Summary: An FDA inspection of Nippon Shikizai, Inc. in Tsukuba, Japan, an OTC drug manufacturer, revealed significant deficiencies in their quality systems. Observations included inadequate cleaning validation for manufacturing equipment, insufficient calibration and verification of production scales, and a lack of written procedures for tracking and managing deviations by the quality assurance unit. These issues indicate a need for improved controls to ensure drug product quality and compliance.

## Related Documents

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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/center-for-veterinary-medicine/7e30a309-56e4-4e7a-8b8b-e07674bb07b4