# FDA 483 - Havix Group Inc - April 19, 2022

Source: https://www.keypedia.com/records/483/havix-group-inc/b1d66927-f26b-40df-ab88-400a83acfcfa

> FDA 483 for Havix Group Inc on April 19, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Havix Group Inc
- Inspection Date: 2022-04-19
- Product Type: drugs
- Office Name: Atlanta District Office
- Summary: Havix Group Inc d/b/a Aavis Pharmaceuticals, a drug manufacturer in Hoschton, GA, was cited for two observations during an FDA inspection. The firm failed to exercise appropriate controls over computer systems, allowing unauthorized personnel administrator rights, and lacked established procedures to prevent objectionable microorganisms. Specifically, issues were noted with cleaning validation for non-dedicated equipment and clean equipment hold times.

## Related Documents

- [483 - 2025-07-25](https://www.keypedia.com/records/483/havix-group-inc/91a17e3d-44a6-4d5b-bfef-3580eb5c56cf)

## Related Officers

- [Susan O. Oladeji](https://www.keypedia.com/people/susan-o-oladeji/307277f8-7704-4ada-8d8d-d77118c6cb77)
- [Gretchen M. Laws](https://www.keypedia.com/people/gretchen-m-laws/9a3ecebd-099b-41d5-a2a7-70811a26cae1)

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

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