FDA Inspection
SpineNet LLC.SpineNet LLC. – FDA Inspection, Feb 1, 2013
Record Details
This FDA Inspection record concerns SpineNet LLC., with an inspection on February 1, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- SpineNet LLC.
- Inspection Date
- February 1, 2013
- Product Type
- Devices
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ID · 76681d5d-ffb3-4bb7-b00d-7c8463bdceec
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 817150
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
14- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.30(c)Design input - documentation
- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.30(h)Design transfer - Lack of or inadequate procedures
- 21 CFR 820.30(f)Design verification - Lack of or inadequate procedures
- 21 CFR 820.140Lack of or inadequate procedures for handling
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
Showing 10 of 14 citations.
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Other FDA inspections of SpineNet LLC.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| April 19, 2024 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| October 9, 2019 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| October 4, 2016 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| February 28, 2014 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for SpineNet LLC.
- FDA Inspection 1239330 - 2024-04-19
- FDA Inspection 1106043 - 2019-10-09
- FDA Inspection 991209 - 2016-10-04
- FDA Inspection 868608 - 2014-02-28
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