FDA Inspection
Allwell Medical CorporationAllwell Medical Corporation – FDA Inspection, Jul 20, 2011
Record Details
This FDA Inspection record concerns Allwell Medical Corporation, with an inspection on July 20, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Allwell Medical Corporation
- Inspection Date
- July 20, 2011
- Product Type
- Devices
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ID · c6e6f4ba-b048-48f9-8d12-09fb0def88aa
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 736566
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
5- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.20(c)Management review - defined interval, sufficient frequency
- 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
- 21 CFR 820.22Quality Audit/Reaudit - conducted
- 21 CFR 820.50(a)(2)Supplier oversight
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Other FDA inspections of Allwell Medical Corporation
3| Date | Classification | Office | Project area |
|---|---|---|---|
| October 24, 2025 | VAI | Atlanta District Office | Compliance: Medical Devices |
| July 2, 2019 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| July 23, 2014 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Allwell Medical Corporation
- FDA Inspection 1289008 - 2025-10-24
- FDA Inspection 1095016 - 2019-07-02
- FDA Inspection 890938 - 2014-07-23
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