Company
United StatesAllwell Medical Corporation, Raleigh, NC – FDA Inspections
Inspection records and compliance data for Allwell Medical Corporation in Raleigh, North Carolina. 4 FDA inspections on record, 2 Form 483s, last inspected October 24, 2025.
Company Profile
This profile covers Allwell Medical Corporation based in Raleigh, North Carolina, United States.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 0
- VAI
- 3
- NAI
- 1
- Form 483s
- 2
- Warning letters
- 0
First inspected July 20, 2011. Last inspected October 24, 2025.
Most cited issue areas
- Acceptable supplier records, inadequate records1 inspection
- Investigation of device failures1 inspection
- Lack of procedures, or not maintained1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| October 24, 2025 | VAI | Medical Devices & Rad Health · Compliance: Medical Devices | 1289008 |
| July 2, 2019 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1095016 |
| July 23, 2014 | NAI | Medical Devices & Rad Health · Compliance: Devices | 890938 |
| July 20, 2011 | VAI | Medical Devices & Rad Health · Compliance: Devices | 736566 |
FDA documents
Form 483s (2)
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Company Information
Name
Allwell Medical Corporation
FEI Number
3007138831
Address
7424 Chapel Hill Rd Ste 204, Raleigh, North Carolina 27607, United States
Country
United States
ID: 8342dffd-678d-4882-a3ff-079d39e495e1