# FDA 483 - HUCK MEDICAL TECHNOLOGIES, Inc. - April 17, 2025

Source: https://www.keypedia.com/records/483/huck-medical-technologies-inc/06323d3d-5d29-4d2e-88e0-4589a01ddc04

> FDA 483 for HUCK MEDICAL TECHNOLOGIES, Inc. on April 17, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: HUCK MEDICAL TECHNOLOGIES, Inc.
- Inspection Date: 2025-04-17
- Product Type: device
- Office Name: Dallas District Office
- Summary: An FDA inspection of HUCK MEDICAL TECHNOLOGIES, Inc. in Jacksonville, TX, a class I device manufacturer, revealed significant deficiencies in their quality system. The firm failed to document management reviews, perform quality audits, and maintain personnel training records. These findings indicate a lack of adherence to established procedures and regulatory expectations for device manufacturing.

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Company: https://www.keypedia.com/companies/huck-medical-technologies-inc/f3696bb2-d28a-4647-80e1-1bcfd8f983b4

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