FDA Inspection
RSB Spine LLCRSB Spine LLC – FDA Inspection, Aug 6, 2013
Record Details
This FDA Inspection record concerns RSB Spine LLC, with an inspection on August 6, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- RSB Spine LLC
- Inspection Date
- August 6, 2013
- Product Type
- Devices
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ID · d0cc626b-e471-4bb1-987a-5e721f81fa89
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 842841
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 820.100(b)Documentation
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
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Other FDA inspections of RSB Spine LLC
5| Date | Classification | Office | Project area |
|---|---|---|---|
| July 28, 2025 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| December 21, 2017 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| December 4, 2014 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| December 13, 2011 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| May 21, 2010 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for RSB Spine LLC
- FDA Inspection 1277043 - 2025-07-28
- FDA Inspection 1035625 - 2017-12-21
- FDA Inspection 904052 - 2014-12-04
- FDA Inspection 756940 - 2011-12-13
- FDA Inspection 663207 - 2010-05-21
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