FDA Inspection
Anatomical Solutions, LLC dba Rapid TraumaAnatomical Solutions, LLC dba Rapid Trauma – FDA Inspection, Jan 15, 2013
Record Details
This FDA Inspection record concerns Anatomical Solutions, LLC dba Rapid Trauma, with an inspection on January 15, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- January 15, 2013
- Product Type
- Devices
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ID · f10a9777-e7d3-4aef-96ab-f5f2beafeb6c
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 814884
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of Anatomical Solutions, LLC dba Rapid Trauma
1| Date | Classification | Office | Project area |
|---|---|---|---|
| March 19, 2014 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Anatomical Solutions, LLC dba Rapid Trauma
- FDA Inspection 874414 - 2014-03-19
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