FDA Inspection
Allwell Medical CorporationAllwell Medical Corporation – FDA Inspection, Jul 2, 2019
Record Details
This FDA Inspection record concerns Allwell Medical Corporation, with an inspection on July 2, 2019, issued by the Center for Devices and Radiological Health, covering devices.
View Company Profile
ID · ec92f735-da59-4ba2-bb53-e0a2d646b6b8
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1095016
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 820.40Lack of procedures, or not maintained
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Allwell Medical Corporation
3| Date | Classification | Office | Project area |
|---|---|---|---|
| October 24, 2025 | VAI | Atlanta District Office | Compliance: Medical Devices |
| July 23, 2014 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| July 20, 2011 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Allwell Medical Corporation
- FDA Inspection 1289008 - 2025-10-24
- FDA Inspection 890938 - 2014-07-23
- FDA Inspection 736566 - 2011-07-20
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.