FDA Inspection
Sandstone Medical Technologies LLCSandstone Medical Technologies LLC – FDA Inspection, May 26, 2009
Record Details
This FDA Inspection record concerns Sandstone Medical Technologies LLC, with an inspection on May 26, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- May 26, 2009
- Product Type
- Devices
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ID · 43c7a92f-69b8-496e-9b21-6bb37bee7957
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 585222
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 820.198(a)(3)Processing MDRs {see also 803, 804}
- 21 CFR 820.100(a)(1)Analysis of data/reports from data sources
- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.181(b)DMR production process specifications
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Other FDA inspections of Sandstone Medical Technologies LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| May 30, 2012 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| April 12, 2010 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Sandstone Medical Technologies LLC
- FDA Inspection 783958 - 2012-05-30
- FDA Inspection 657195 - 2010-04-12
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