Spinal Solutions, LLC
FDA inspection history in Murrieta, California, 2011 to 2012
- 2
- Form 483s
- 1
- Warning letter
Every document, by year
- Form 483
- Warning letter
2011: one Form 483; 2012: one Form 483 and one warning letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2011–12Two Form 483s and one warning letter, at Murrieta, California.
- 2011The longest 483 on file: 16 observations over 8 pages at Murrieta, California.
Cited most
Across all Spinal Solutions observations on file
- 21 CFR 820.20(a)Management responsibility4
- 21 CFR 820.120Device labeling2
- 21 CFR 820.50Purchasing controls2
- 21 CFR 820.80(b)Receiving, in-process, and finished device acceptance2
- 21 CFR 8201
The complete Spinal Solutions file.
All 3 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Murrieta, California
Two Form 483s and one warning letter · 2011 to 2012 · 20 observations
Latest: Form 483, Sep 11, 2012 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2012-09-11 | 483 Form 483 | Murrieta, California | 4 | $99 |
| 2012-01-19 | Warning letter Warning letter | Murrieta, California | — | $99 |
| 2011-09-15 | 483 Form 483 | Murrieta, California | 16 | $99 |
Investigators on these documents
Sonya L. Karsik (2)Dejon N. Harris (1)Marcus F. Yambot (1)Minh D. Phan (1)
FEI number 3004884943 · most recent document Sep 11, 2012
About Spinal Solutions, LLC
How many FDA Form 483s has Spinal Solutions, LLC received?
FDA Intel has 2 Form 483s on file for Spinal Solutions, LLC; the most recent is dated Sep 11, 2012.
When was Spinal Solutions, LLC last inspected by FDA?
The most recent FDA inspection document on file for Spinal Solutions, LLC is a Form 483 dated Sep 11, 2012, for the site in Murrieta, California.
What did FDA cite at Spinal Solutions, LLC?
The regulations cited most in the observations on file for Spinal Solutions, LLC are 21 CFR 820.20(a) (Management responsibility), 4 times; 21 CFR 820.120 (Device labeling), 2 times; 21 CFR 820.50 (Purchasing controls), 2 times.
Has Spinal Solutions, LLC received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Spinal Solutions, LLC; the most recent is dated Jan 19, 2012.