# FDA 483 - Robling Medical Inc - August 21, 2025

Source: https://www.keypedia.com/records/483/robling-medical-inc/767d7269-a5a3-4d5e-83e7-b77a3b37a416

> FDA 483 for Robling Medical Inc on August 21, 2025. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Robling Medical Inc
- Inspection Date: 2025-08-21
- Product Type: other
- Office Name: Atlanta District Office
- Summary: Robling Medical LLC, a contract manufacturer in Youngsville, NC, was inspected by the FDA from August 18-21, 2025. The inspection revealed a significant issue with the firm's corrective and preventive action (CAPA) system, specifically regarding incomplete documentation and discrepancies in closure dates on the CAPA log. This indicates a breakdown in quality system controls.

## Related Documents

- [483 - 2019-11-26](https://www.keypedia.com/records/483/robling-medical-inc/493e15c8-6540-4cb0-9fdc-f412e7998627)

## Related Officers

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

Company: https://www.keypedia.com/companies/robling-medical-inc/98ba95cf-1a99-4ac9-adc4-d87193511cd9

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