# FDA 483 - Havix Group Inc - July 25, 2025

Source: https://www.globalkeysolutions.net/records/483/havix-group-inc/91a17e3d-44a6-4d5b-bfef-3580eb5c56cf

> FDA 483 for Havix Group Inc on July 25, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Havix Group Inc
- Inspection Date: 2025-07-25
- Product Type: drugs
- Office Name: Atlanta District Office
- Summary: An FDA inspection of Havix Group Inc in Hoschton, GA, a drug manufacturer, revealed significant deficiencies in process validation, equipment cleaning procedures, and personnel gowning practices. The firm failed to adequately address the potential impact of operating at extreme batch record ranges on product quality and stability. Additionally, cleaning procedures for equipment were found to be deficient, and an operator was observed not wearing required protective apparel while handling drug product.

## Related Documents

- [483 - 2022-04-19](https://www.globalkeysolutions.net/records/483/havix-group-inc/b1d66927-f26b-40df-ab88-400a83acfcfa)

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/anthony-j-donato/a6dd6e14-529e-4b23-9b5f-02c88afb80ae)
- [investigator](https://www.globalkeysolutions.net/people/tammy-t-brown/d83095ba-80a1-4006-b429-d8c0d49fcd2b)

Company: https://www.globalkeysolutions.net/companies/havix-group-inc/f038f97b-b3a3-4e4d-87d3-1366860c7e6d

Office: https://www.globalkeysolutions.net/offices/atlanta-district-office/7586d99a-288e-49d1-8c3d-d88b7354b7a7