# FDA 483 - VASTMED LLC - July 23, 2025

Source: https://www.keypedia.com/records/483/vastmed-llc/eca4d3d3-aba6-4e6b-b86f-f3aebefc65af

> FDA 483 for VASTMED LLC on July 23, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: VASTMED LLC
- Inspection Date: 2025-07-23
- Product Type: device
- Office Name: Dallas District Office
- Summary: VASTMED LLC, a medical device manufacturer in Grand Prairie, TX, was cited for significant deficiencies in its quality system during an FDA inspection. The firm lacks established procedures for incoming product acceptance, nonconforming material control, and Medical Device Reporting (MDRs). Additionally, its medical device labels do not comply with Unique Device Identifier (UDI) regulations, and product information has not been registered with the GUDID.

## Related Officers

- [Katlin N. Stubbs](https://www.keypedia.com/people/katlin-n-stubbs/27d70db1-a2e9-4254-a721-c6de655f7626)

Company: https://www.keypedia.com/companies/vastmed-llc/7d021065-9995-49e7-9f61-83acdb513580

Office: https://www.keypedia.com/offices/dallas-district-office/2d1ee9ae-c44c-4494-8186-a920a69b98f9