FDA Inspection
SMK Imaging LLCSMK Imaging LLC – FDA Inspection, Apr 29, 2013
Record Details
This FDA Inspection record concerns SMK Imaging LLC, with an inspection on April 29, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- SMK Imaging LLC
- Inspection Date
- April 29, 2013
- Product Type
- Devices
View Company Profile
ID · dda26785-7710-4507-a3fd-2721e8df2b44
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 830365
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
Other FDA inspections of SMK Imaging LLC
5| Date | Classification | Office | Project area |
|---|---|---|---|
| March 28, 2022 | NAI | Center for Devices and Radiological Health | Radiation Control and Health Safety Act |
| October 23, 2019 | NAI | Center for Devices and Radiological Health | Radiation Control and Health Safety Act |
| August 16, 2017 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| August 7, 2015 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| April 15, 2010 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for SMK Imaging LLC
- FDA Inspection 1166300 - 2022-03-28
- FDA Inspection 1108788 - 2019-10-23
- FDA Inspection 1022746 - 2017-08-16
- FDA Inspection 940586 - 2015-08-07
- FDA Inspection 657556 - 2010-04-15
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