# FDA 483 - Practicon Inc - February 26, 2026

Source: https://www.keypedia.com/records/483/practicon-inc/cb609d8b-a3b0-46ba-baf8-cca860009453

> FDA 483 for Practicon Inc on February 26, 2026. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Practicon Inc
- Inspection Date: 2026-02-26
- Product Type: device
- Office Name: Atlanta District Office
- Summary: Practicon Inc, a repackager/relabeler in Greenville, NC, was inspected and cited for significant deficiencies in its quality management system. The inspection revealed failures in maintaining records of risk management activities for its Class II medical device, the Practicon Acu-Tip Cauterizing Instrument. Additionally, the firm lacked adequate management review processes and failed to ensure necessary personnel competence through proper training.

## Related Officers

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

Company: https://www.keypedia.com/companies/practicon-inc/c2bdf6fe-d613-42b7-b3c2-023b42643ab8

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