# FDA 483 - ALOM Technologies Corporation - October 17, 2024

Source: https://www.keypedia.com/records/483/alom-technologies-corporation/4a5ee332-e150-424a-809e-b9fd26d73cef

> FDA 483 for ALOM Technologies Corporation on October 17, 2024. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: ALOM Technologies Corporation
- Inspection Date: 2024-10-17
- Product Type: device
- Office Name: Detroit District Office
- Summary: ALOM Technologies Corporation in Indianapolis, IN, was inspected by the FDA from October 15-17, 2024. The inspection revealed that the firm's procedures for corrective and preventive action (CAPA) were not adequately established. This led to undocumented changes in their inventory management system and Device History Record documentation, indicating deficiencies in their quality system controls.

## Related Officers

- [Melina L. Rodriguez-Upton](https://www.keypedia.com/people/melina-l-rodriguez-upton/0b540980-5708-4251-8ea6-6254375506f1)

Company: https://www.keypedia.com/companies/alom-technologies-corporation/a0c41094-59ce-4ab2-8425-761c71448fcd

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