# FDA 483 - Electro Medical Systems, LLC - October 21, 2025

Source: https://www.keypedia.com/records/483/electro-medical-systems-llc/324ed5fd-f5ac-48d4-9a1c-9fd0e88ec276

> FDA 483 for Electro Medical Systems, LLC on October 21, 2025. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Electro Medical Systems, LLC
- Inspection Date: 2025-10-21
- Product Type: device
- Office Name: Dallas District Office
- Summary: An FDA inspection of Electro Medical Systems, LLC in Southlake, TX, a remanufacturer and repackager/relabeler, revealed significant deficiencies in its quality system. Observations included inadequate supplier control, poor document control practices, and a lack of documented personnel training. These issues suggest a need for comprehensive corrective actions to ensure compliance with regulatory requirements.

## Related Officers

- [Elizabeth A. Krolczyk](https://www.keypedia.com/people/elizabeth-a-krolczyk/ecf57c43-b88d-4f84-962b-9067eaad4a7c)

Company: https://www.keypedia.com/companies/electro-medical-systems-llc/8fe1590e-6843-407a-bc05-1bcfcce34341

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