FDA Inspection
Baxano, Inc.Baxano, Inc. – FDA Inspection, Nov 30, 2010
Record Details
This FDA Inspection record concerns Baxano, Inc., with an inspection on November 30, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Baxano, Inc.
- Inspection Date
- November 30, 2010
- Product Type
- Devices
View Company Profile
ID · c294e7d5-0d7b-4011-babe-8ab0133d2bca
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 698004
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
3- 21 CFR 803.50(a)(1)Report of Death or Serious Injury
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.75(c)Documentation - review in response to changes or deviations
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Baxano, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| February 1, 2011 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Baxano, Inc.
- FDA Inspection 707782 - 2011-02-01
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