FDA Inspection
Sonogage IncSonogage Inc – FDA Inspection, Jul 26, 2013
Record Details
This FDA Inspection record concerns Sonogage Inc, with an inspection on July 26, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Sonogage Inc
- Inspection Date
- July 26, 2013
- Product Type
- Devices
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ID · c8bb3d0b-eacf-4350-9cc5-9baa13131b95
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 843975
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
11- 21 CFR 820.40Lack of procedures, or not maintained
- 21 CFR 108.25(e)Recall procedures
- 21 CFR 820.25(b)Training records
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.75(a)Documentation
Showing 10 of 11 citations.
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Other FDA inspections of Sonogage Inc
4| Date | Classification | Office | Project area |
|---|---|---|---|
| April 25, 2023 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 21, 2018 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| September 12, 2014 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| July 31, 2009 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Sonogage Inc
- FDA Inspection 1203721 - 2023-04-25
- FDA Inspection 1045173 - 2018-03-21
- FDA Inspection 895282 - 2014-09-12
- FDA Inspection 601020 - 2009-07-31
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