# FDA 483 - D3W Industries Inc - January 17, 2025

Source: https://www.globalkeysolutions.net/records/483/d3w-industries-inc/71c232bc-d7b2-43ba-90e0-daba9f198cab

> FDA 483 for D3W Industries Inc on January 17, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: D3W Industries Inc
- Inspection Date: 2025-01-17
- Product Type: drugs
- Office Name: Detroit District Office
- Summary: D3W Industries Inc, a drug repackager in Novi, MI, was inspected by the FDA, revealing a significant absence of a quality control unit. The inspection also cited a lack of established cGMP procedures for critical operations such as deviations, change controls, and the repacking and relabeling of hand sanitizer. These findings indicate fundamental deficiencies in the firm's quality system.

## Related Officers

- [Shannon L. Maisano](https://www.globalkeysolutions.net/people/shannon-l-maisano/2cce259d-0fbe-44ef-b43e-7292da739470)
- [Nicholas J. Presto](https://www.globalkeysolutions.net/people/nicholas-j-presto/2ecdd573-6662-4d07-b93c-ddb9c603bcfa)

Company: https://www.globalkeysolutions.net/companies/d3w-industries-inc/ef6ecf67-bcb2-45f7-8c48-ba9c52b9642c

Office: https://www.globalkeysolutions.net/offices/detroit-district-office/b09a1815-a000-40c0-bb44-5432ce87ed03