483
Allwell Medical CorporationAllwell Medical Corporation – FDA 483, Oct 24, 2025
Record Details
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.
- Office
- Atlanta District Office
- Person
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ID · 472f16cc-cbc9-4cc4-b783-0d78df62e286
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