# FDA 483 - Daizo Corporation - November 06, 2023

Source: https://www.keypedia.com/records/483/daizo-corporation/2a527e76-7ab1-467c-91d2-29161535bf78

> 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: Baltimore District Office
- Summary: An FDA inspection of Daizo Corporation's Kyoto, Japan facility, an OTC drug manufacturer, was conducted from October 30 to November 6, 2023. This inspection resulted in a Form FDA 483, identifying three significant observations regarding the firm's adherence to Good Manufacturing Practices (GMP). The first observation noted deficiencies in laboratory records, specifically concerning gas chromatography (GC) testing. It was found that repeated sample analyses were conducted on multiple occasions for drug product lots destined for the US market. Crucially, the reasons for these repeated analyses were not documented, and only the final, repeated results were included in finished product records, indicating a lack of data integrity. Secondly, the FDA observed inadequate controls over computer systems. Daizo Corporation lacked written procedures for reviewing audit trails associated with their GC software, which is used for analyzing products, including those for the US market. Quality Control personnel confirmed that these audit trails were not routinely reviewed, raising concerns about unauthorized changes to data. Finally, laboratory controls were found to be insufficient, particularly concerning cleaning validation. The company lacked scientific data to support established cleaning validation specification limits for active pharmaceutical ingredient residue on multi-product equipment. Furthermore, Daizo Corporation utilized un-evaluated customer laboratories to analyze cleaning validation swab samples for certain products, compromising the reliability of these tests. Daizo Corporation is required to address these observations promptly with comprehensive corrective and preventive actions to ensure compliance with regulatory standards for drug manufacturing.

## Related Documents

- [483 - 2023-11-06](https://www.keypedia.com/records/483/daizo-corporation/5199cc08-4f0a-4beb-bf96-254d2c448111)
- [483 - 2023-11-06](https://www.keypedia.com/records/483/daizo-corporation/f85e15ae-902c-416b-8048-59a4d8d74f39)

## Related Officers

- [Drug Discovery and Biotech Executive](https://www.keypedia.com/people/lloyd-d-payne/8b98c38a-4fbe-465d-bb0a-689bcc6db702)
- [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/baltimore-district-office/6be371ff-03e9-4039-999c-ff170f17a9fa