FDA Inspection
Origami Surgical LLCOrigami Surgical LLC – FDA Inspection, Jun 14, 2018
Record Details
This FDA Inspection record concerns Origami Surgical LLC, with an inspection on June 14, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 20c5073d-9295-4fc1-927f-364242494b08
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1056032
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 820.30(g)Design validation - documentation
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Other FDA inspections of Origami Surgical LLC
1| Date | Classification | Office | Project area |
|---|---|---|---|
| July 3, 2014 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Origami Surgical LLC
- FDA Inspection 885543 - 2014-07-03
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