SpineSmith Holdings, LLC
Form 483 issued February 13, 2026 · Austin, Texas
- Inspection
- Feb 9 – Feb 13, 2026
- Investigator
- Katherine M. Thames
- Observations
- 2
- Pages
- 4
- FEI number
- 3006404071
In short: On February 13, 2026, FDA issued a Form 483 with 2 observations to SpineSmith Holdings, LLC in Austin, Texas (FEI 3006404071) after an inspection that ran Feb 9 – Feb 13, 2026. The investigator was Katherine M. Thames. Most observations concern design controls and production & process controls; the most-cited regulation is 21 CFR 820.30 (design controls).
At a glance
Design controls and production & process controls account for 2 of 2 observations.
Most cited: 21 CFR 820.30 (1×) · 820.80 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
In product realization planning your firm did not adequately determine, as appropriate, quality objectives and requirements…
- 02
The inspection or other activities necessary for ensuring that purchased product meets specified purchasing requirements were…
This inspection in context
Katherine M. Thames
6 documents · 2025–2026
Cites 820.198(a) (complaint files) more than any other section. Most of their documents are for sites in Texas.
The firmSpineSmith Holdings, LLC history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 820.30
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at SpineSmith Holdings, LLC?
FDA listed 2 observations on this Form 483, mostly about design controls and production & process controls. The most-cited regulation is 21 CFR 820.30 (design controls). The opening words of each observation are shown on this page.
Who inspected SpineSmith Holdings, LLC?
Katherine M. Thames is named on this Form 483, for the inspection of Feb 9 – Feb 13, 2026. Each investigator has a profile showing what they cite most.
When was SpineSmith Holdings, LLC inspected by FDA?
The inspection ran Feb 9 – Feb 13, 2026, and the Form 483 is dated February 13, 2026.
How do I get the full Form 483 for SpineSmith Holdings, 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.