483
Aiomega, LLCFDA 483 - Aiomega, LLC
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Record Details
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.
- Company
- Aiomega, LLC
- Product Type
- Device
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ID · 047296cb-a2b0-468d-a062-c35d73b97cc1