# FDA 483 - Robling Medical Inc - April 06, 2026

Source: https://www.keypedia.com/records/483/robling-medical-inc/38838696-470b-4ebc-af28-2f17048125dd

> FDA 483 for Robling Medical Inc on April 06, 2026. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Robling Medical Inc
- Inspection Date: 2026-04-06
- Product Type: device
- Office Name: Atlanta District Office
- Summary: Robling Medical LLC, a contract manufacturer in Youngsville, NC, was inspected by the FDA and received a Form 483 with two observations. The inspection revealed significant delays in implementing corrective and preventive actions (CAPAs) and a failure to adequately document risk management processes, specifically a Process Failure Mode and Effects Analysis (PFMEA) for a sterile medical device. These issues indicate deficiencies in the firm's quality system regarding timely issue resolution and risk assessment.

## Related Documents

- [483 - 2019-11-26](https://www.keypedia.com/records/483/robling-medical-inc/493e15c8-6540-4cb0-9fdc-f412e7998627)
- [483 - 2025-08-21](https://www.keypedia.com/records/483/robling-medical-inc/767d7269-a5a3-4d5e-83e7-b77a3b37a416)

## Related Officers

- [Lashawn M. Elam](https://www.keypedia.com/people/lashawn-m-elam/23bee423-c2f7-4977-bc32-2d4c40fc521f)
- [Christopher B. May](https://www.keypedia.com/people/christopher-b-may/b2173a59-d37b-41f1-aa39-eefd854722b8)

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