# FDA 483 - Allwell Medical Corporation - October 24, 2025

Source: https://www.keypedia.com/records/483/allwell-medical-corporation/472f16cc-cbc9-4cc4-b783-0d78df62e286

> FDA 483 for Allwell Medical Corporation on October 24, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Allwell Medical Corporation
- Inspection Date: 2025-10-24
- Product Type: device
- Office Name: Atlanta District Office
- Summary: Allwell Medical Corporation in Raleigh, NC, was inspected from October 22-24, 2025, and received a Form FDA 483 with two observations. The inspection revealed deficiencies in the firm's written Medical Device Reporting (MDR) procedures and inadequate establishment of records for acceptable consultants. These issues indicate a need for improved quality system controls regarding adverse event reporting and supplier management.

## Related Documents

- [483 - 2019-07-02](https://www.keypedia.com/records/483/allwell-medical-corporation/67a2a803-6e12-4805-8a7a-aa6f0a1ce79f)

## Related Officers

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

Company: https://www.keypedia.com/companies/allwell-medical-corporation/8342dffd-678d-4882-a3ff-079d39e495e1

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