SpineSmith Holdings, LLC
FDA inspection history in Austin, Texas, 2026
- 2
- Form 483s
Every document, by year
- Form 483
2026: two Form 483s.
The story so far
Built from the dates and citations on the documents themselves.
- 2026Two Form 483s, at Austin, Texas.
- 2026The longest 483 on file: 2 observations over 4 pages at Austin, Texas.
Cited most
Across all SpineSmith Holdings observations on file
- ISO 13485:2016 Clause 7.1Scope1
- 21 CFR 820.30Design controls1
- 21 CFR 820.80Receiving, in-process, and finished device acceptance1
The complete SpineSmith Holdings file.
All 2 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
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Sites
Austin, Texas
Two Form 483s · 2026 · 4 observations
Latest: Form 483, Feb 13, 2026 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2026-02-13 | 483 Form 483 | Austin, Texas | 2 | $99 |
| 2026-02-13 | 483 Form 483 | Austin, Texas | 2 | $99 |
Investigators on these documents
FEI number 3006404071 · most recent document Feb 13, 2026
About SpineSmith Holdings, LLC
How many FDA Form 483s has SpineSmith Holdings, LLC received?
FDA Intel has 2 Form 483s on file for SpineSmith Holdings, LLC; the most recent is dated Feb 13, 2026.
When was SpineSmith Holdings, LLC last inspected by FDA?
The most recent FDA inspection document on file for SpineSmith Holdings, LLC is a Form 483 dated Feb 13, 2026, for the site in Austin, Texas.
What did FDA cite at SpineSmith Holdings, LLC?
The regulations cited most in the observations on file for SpineSmith Holdings, LLC are ISO 13485:2016 Clause 7.1 (Scope), 1 time; 21 CFR 820.30 (Design controls), 1 time; 21 CFR 820.80 (Receiving, in-process, and finished device acceptance), 1 time.