# FDA 483 - Aiomega, LLC - Unknown Date

Source: https://www.globalkeysolutions.net/records/483/aiomega-llc/047296cb-a2b0-468d-a062-c35d73b97cc1

> FDA 483 for Aiomega, LLC on Unknown Date. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Aiomega, LLC
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West III
- Summary: Aiomega LLC, a device manufacturer in Tyler, TX, was inspected by the FDA from June 30 to July 2, 2025. The inspection resulted in one observation concerning the firm's quality system. Specifically, the firm failed to perform required risk analysis for non-product software used in its manufacturing process.

## Related Officers

- [Amber Smith](https://www.globalkeysolutions.net/people/amber-smith/2395fa1b-d091-4227-a340-9d6991c394fa)

Company: https://www.globalkeysolutions.net/companies/aiomega-llc/8dab794b-1e5e-43cc-ac5c-64db07e43269

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-west-iii/2cda09a5-06c4-433f-9df0-0d7903a6efab