FDA Inspection
Allwell Medical CorporationAllwell Medical Corporation – FDA Inspection, Oct 24, 2025
Record Details
This FDA Inspection record concerns Allwell Medical Corporation, with an inspection on October 24, 2025, issued by the Atlanta District Office, covering medical devices & rad health.
- Company
- Allwell Medical Corporation
- Inspection Date
- October 24, 2025
- Product Type
- Medical Devices & Rad Health
View Company Profile
ID · a2b99911-b4f6-4ca3-bda1-870100ee45ed
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1289008
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Medical Devices
FDA Citations
2- 21 CFR 820.50(a)(3)Acceptable supplier records, inadequate records
- 21 CFR 803.17(a)(2)Lack of System for Determining MDR Events
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Allwell Medical Corporation
3| Date | Classification | Office | Project area |
|---|---|---|---|
| July 2, 2019 | VAI | Center for Devices and Radiological Health | Compliance: 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 1095016 - 2019-07-02
- FDA Inspection 890938 - 2014-07-23
- FDA Inspection 736566 - 2011-07-20
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