Spinal Solutions, LLC
Form 483 issued September 15, 2011 · Murrieta, California
- Inspection
- Jul 11 – Sep 15, 2011
- Investigator
- Sonya L. Karsik
- Observations
- 16
- Pages
- 8
- FEI number
- 3004884943
In short: On September 15, 2011, FDA issued a Form 483 with 16 observations to Spinal Solutions, LLC in Murrieta, California (FEI 3004884943) after an inspection that ran Jul 11 – Sep 15, 2011. The investigator was Sonya L. Karsik. Most observations concern production & process controls and management controls; the most-cited regulation is 21 CFR 820.20 (management responsibility).
At a glance
Production & process controls and management controls account for 12 of 16 observations.
What FDA observed
Preview: the opening words of each observation- 01
The device history record does not demonstrate that the device was manufactured in accordance with…
- 02
A device master record…
- 03
Procedures for finished device acceptance…
- 04
Procedures for acceptance of incoming product…
This inspection in context
Sonya L. Karsik
9 documents · 2009–2019
Cites 820.30 (design controls) 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 820.184
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Spinal Solutions, LLC?
FDA listed 16 observations on this Form 483, mostly about production & process controls, management controls and records & documents. The most-cited regulation is 21 CFR 820.20 (management responsibility). The opening words of each observation are shown on this page.
Who inspected Spinal Solutions, LLC?
Sonya L. Karsik is named on this Form 483, for the inspection of Jul 11 – Sep 15, 2011. Each investigator has a profile showing what they cite most.
When was Spinal Solutions, LLC inspected by FDA?
The inspection ran Jul 11 – Sep 15, 2011, and the Form 483 is dated September 15, 2011.
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.