FDA Inspection
American ImexAmerican Imex – FDA Inspection, May 18, 2015
Record Details
This FDA Inspection record concerns American Imex, with an inspection on May 18, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- American Imex
- Inspection Date
- May 18, 2015
- Product Type
- Devices
View Company Profile
ID · c211a0c8-67b0-47c4-a206-f399d4265d12
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 927130
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
6- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.20(c)Management review - defined interval, sufficient frequency
- 21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.22Quality Audit/Reaudit - conducted
- 21 CFR 820.20(a)Quality policy and objectives
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Other FDA inspections of American Imex
2| Date | Classification | Office | Project area |
|---|---|---|---|
| January 20, 2016 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| December 16, 2011 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for American Imex
- FDA Inspection 958092 - 2016-01-20
- FDA Inspection 758825 - 2011-12-16
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