Spinal Solutions, LLC
Form 483 issued September 11, 2012 · Murrieta, California
- Inspection
- Jul 25 – Sep 11, 2012
- Investigators
- Dejon N. Harris· Marcus F. Yambot· Minh D. Phan
- Observations
- 4
- Pages
- 3
- FEI number
- 3004884943
In short: On September 11, 2012, FDA issued a Form 483 with 4 observations to Spinal Solutions, LLC in Murrieta, California (FEI 3004884943) after an inspection that ran Jul 25 – Sep 11, 2012. The investigators were Dejon N. Harris, Marcus F. Yambot, Minh D. Phan and Sonya L. Karsik. Most observations concern production & process controls and design controls.
At a glance
2 of 3 observations on this 483 concern production & process controls.
What FDA observed
Preview: the opening words of each observation- 01
Procedures for design control…
- 03
Procedures to ensure that all purchased or otherwise received product and services conform to specified requirements…
- 04
Procedures to control labeling activities…
This inspection in context
Dejon N. Harris
1 document · 2012
Cites 820.120 (device labeling) more than any other section. Most of their documents are for sites in California.
The firmSpinal Solutions, LLC history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 820.30(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Spinal Solutions, LLC?
FDA listed 4 observations on this Form 483, mostly about production & process controls and design controls. The opening words of each observation are shown on this page.
Who inspected Spinal Solutions, LLC?
Dejon N. Harris, Marcus F. Yambot, Minh D. Phan and Sonya L. Karsik are named on this Form 483, for the inspection of Jul 25 – Sep 11, 2012. Each investigator has a profile showing what they cite most.
When was Spinal Solutions, LLC inspected by FDA?
The inspection ran Jul 25 – Sep 11, 2012, and the Form 483 is dated September 11, 2012.
How do I get the full Form 483 for Spinal Solutions, LLC?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.