FDA 483 - Allwell Medical Corporation - October 24, 2025

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.