# FDA 483 - Argon Medical Devices, Inc - March 19, 2024

Source: https://www.keypedia.com/records/483/argon-medical-devices-inc/e4cda975-dafe-4b80-b7dd-af68268ce589

> FDA 483 for Argon Medical Devices, Inc on March 19, 2024. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Argon Medical Devices, Inc
- Inspection Date: 2024-03-19
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West III
- Summary: An FDA inspection of Argon Medical Devices, Inc. in Athens, TX, revealed significant deficiencies in its quality system. The firm failed to adequately investigate customer complaints regarding device failures, particularly repeated issues with guidewires, and did not consistently evaluate complaints for MDR reportability. Additionally, personnel training records were found to be incomplete and not readily available, indicating a lack of proper documentation for employee training.

## Related Officers

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

Company: https://www.keypedia.com/companies/argon-medical-devices-inc/faa6d7fb-142e-4639-b975-d5c78e376daa

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