FDA Inspection
American ImexAmerican Imex – FDA Inspection, Jan 20, 2016
Record Details
This FDA Inspection record concerns American Imex, with an inspection on January 20, 2016, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- American Imex
- Inspection Date
- January 20, 2016
- Product Type
- Devices
View Company Profile
ID · be895fb3-268e-48b6-8580-9cda40f4e0a5
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 958092
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
3- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
- 21 CFR 803.17Lack of Written MDR Procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of American Imex
2| Date | Classification | Office | Project area |
|---|---|---|---|
| May 18, 2015 | 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 927130 - 2015-05-18
- FDA Inspection 758825 - 2011-12-16
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