# FDA 483 - Daizo Corporation - November 06, 2023

Source: https://www.keypedia.com/records/483/daizo-corporation/5199cc08-4f0a-4beb-bf96-254d2c448111

> FDA 483 for Daizo Corporation on November 06, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Daizo Corporation
- Inspection Date: 2023-11-06
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Daizo Corporation, an OTC drug manufacturer in Kyoto, Japan, was cited for significant deficiencies during an FDA inspection. Observations included incomplete laboratory records due to undocumented repeated sample analyses, inadequate computer system controls with unreviewed audit trails for GC software, and insufficient laboratory controls regarding cleaning validation specifications and the use of un-evaluated customer laboratories. These issues indicate a lack of robust quality control and data integrity practices.

## Related Documents

- [483 - 2023-11-06](https://www.keypedia.com/records/483/daizo-corporation/f85e15ae-902c-416b-8048-59a4d8d74f39)

## Related Officers

- [Seneca D. Toms](https://www.keypedia.com/people/seneca-d-toms/3eda62a2-4c12-438f-805a-5e3efb0f2f94)

Company: https://www.keypedia.com/companies/daizo-corporation/7a66968e-4435-4dee-9c89-fa5c0a16db7a

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