FDA Inspection
SMK Imaging LLCSMK Imaging LLC – FDA Inspection, Aug 7, 2015
Record Details
This FDA Inspection record concerns SMK Imaging LLC, with an inspection on August 7, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- SMK Imaging LLC
- Inspection Date
- August 7, 2015
- Product Type
- Devices
View Company Profile
ID · cb79f150-d40f-45e0-a268-279be756ff52
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 940586
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 820.30(d)Design output - review and approval
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
Full citation text and observation details available on the Dashboard.
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 |
| 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 1108788 - 2019-10-23
- FDA Inspection 1022746 - 2017-08-16
- FDA Inspection 830365 - 2013-04-29
- FDA Inspection 657556 - 2010-04-15
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