FDA Inspection
United Metal Fabricators IncUnited Metal Fabricators Inc – FDA Inspection, Apr 27, 2017
Record Details
This FDA Inspection record concerns United Metal Fabricators Inc, with an inspection on April 27, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · f483786e-5e68-4e06-b612-bdfa777c092f
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1024997
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
7- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 820.20(b)Lack of or inadequate organizational structure
- 21 CFR 820.20(c)Management review dates
- 21 CFR 820.22Quality Audit/Reaudit - conducted
- 21 CFR 820.25(b)Training records
- 21 CFR 820.50(a)(1)Documented evaluation
- 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of United Metal Fabricators Inc
5| Date | Classification | Office | Project area |
|---|---|---|---|
| August 12, 2025 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 27, 2013 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| August 8, 2011 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| April 21, 2011 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| October 17, 2008 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for United Metal Fabricators Inc
- FDA Inspection 1278960 - 2025-08-12
- FDA Inspection 838481 - 2013-06-27
- FDA Inspection 739543 - 2011-08-08
- FDA Inspection 721319 - 2011-04-21
- FDA Inspection 542648 - 2008-10-17
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