# FDA 483 - Hensler Surgical Products, LLC - December 11, 2025

Source: https://www.keypedia.com/records/483/hensler-surgical-products-llc/69b5a3a1-347c-4bb7-ab86-0b584c0c3d29

> FDA 483 for Hensler Surgical Products, LLC on December 11, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Hensler Surgical Products, LLC
- Inspection Date: 2025-12-11
- Product Type: device
- Office Name: Atlanta District Office
- Summary: Hensler Surgical Products, LLC in Wilmington, NC, was inspected and received a Form FDA 483 with two observations. The inspection revealed significant deficiencies in personnel training and the firm's quality audit system. These issues indicate a lack of adherence to quality system requirements, potentially impacting product quality and regulatory compliance.

## Related Officers

- [Lashawn M. Elam](https://www.keypedia.com/people/lashawn-m-elam/23bee423-c2f7-4977-bc32-2d4c40fc521f)

Company: https://www.keypedia.com/companies/hensler-surgical-products-llc/cbd94f61-0b78-4b71-8384-3644563c56ba

Office: https://www.keypedia.com/offices/atlanta-district-office/7586d99a-288e-49d1-8c3d-d88b7354b7a7