FDA Inspection
SMK Imaging LLCSMK Imaging LLC – FDA Inspection, Oct 23, 2019
Record Details
This FDA Inspection record concerns SMK Imaging LLC, with an inspection on October 23, 2019, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- SMK Imaging LLC
- Inspection Date
- October 23, 2019
- Product Type
- Devices
View Company Profile
ID · bf3b4d1c-0313-4f2b-bdb8-539f822461f9
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1108788
- FDA center
- Medical Devices & Rad Health
- Project area
- Radiation Control and Health Safety Act
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 |
| 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 29, 2013 | 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 1022746 - 2017-08-16
- FDA Inspection 940586 - 2015-08-07
- FDA Inspection 830365 - 2013-04-29
- FDA Inspection 657556 - 2010-04-15
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