FDA Inspection
Statrad, LLCStatrad, LLC – FDA Inspection, Oct 30, 2019
Record Details
This FDA Inspection record concerns Statrad, LLC, with an inspection on October 30, 2019, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Statrad, LLC
- Inspection Date
- October 30, 2019
- Product Type
- Devices
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ID · b516e6bf-3310-46bd-9722-15db0714e73a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1108314
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.30(c)Design input - Lack of or inadequate procedures
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
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Other FDA inspections of Statrad, LLC
3| Date | Classification | Office | Project area |
|---|---|---|---|
| April 20, 2023 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| July 16, 2015 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 8, 2011 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Statrad, LLC
- FDA Inspection 1205404 - 2023-04-20
- FDA Inspection 934727 - 2015-07-16
- FDA Inspection 729860 - 2011-06-08
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