FDA-Inspected Site

SpineFrontier, Inc.

7 FDA inspections are on record for SpineFrontier, Inc. in Burlington, United States.

483· Form 483 issued

Burlington, United States · Last updated July 10, 2026

Overview

  • 7 FDA inspections are on record.
  • 4 inspections produced a Form 483.
  • The most recent recorded inspection date is 2026-04-02.

At a glance

Inspections

7

Form 483s

4

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
30 Mar 2026 – 2 Apr 2026Medical Devices & Rad Health483View 483 →
23 Jan 2019 – 29 Jan 2019Medical Devices & Rad Health483On file
29 Nov 2017BiologicsClean
9 Feb 2016 – 10 Feb 2016BiologicsClean
22 Jul 2013 – 5 Aug 2013Medical Devices & Rad HealthClean
11 Jul 2012Not recordedWLView 483 →
3 Apr 2008Not recorded483On file

Observations on record

Form 483 observations cited at this site, most recent first.

2 Apr 2026
ISO 13485:2016 Clause 8.5.2

Corrective action records not maintained

Cited by Nabil Nakhoul

2 Apr 2026
ISO 13485:2016 Clause 8.5.2

Corrective action records not maintained

Cited by Nabil Nakhoul

11 Jul 2012
21 CFR 803.50(a)(2)

Report of Malfunction

Cited by Tamara S Rosbury

11 Jul 2012
21 CFR 806.20(b)(4)

Justification for not reporting

Cited by Tamara S Rosbury

11 Jul 2012
21 CFR 820.25(b)

Training - Lack of or inadequate procedures

Cited by Tamara S Rosbury

Investigators

FDA investigators tied to this site in the record.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
ISO 13485:2016 Clause 8.5.2Cited across public-safe Form 483 observations2x
21 CFR 803.50(a)(2)Cited across public-safe Form 483 observations1x
21 CFR 806.20(b)(4)Cited across public-safe Form 483 observations1x
21 CFR 820.100(a)Cited across public-safe Form 483 observations1x
21 CFR 820.198(a)Cited across public-safe Form 483 observations1x
21 CFR 820.25(b)Cited across public-safe Form 483 observations1x
21 CFR 820.30(f)Cited across public-safe Form 483 observations1x
21 CFR 820.30(g)Cited across public-safe Form 483 observations1x
21 CFR 820.50(b)Cited across public-safe Form 483 observations1x
21 CFR 820.75(c)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind SpineFrontier, Inc.'s 4 Form 483s

Verbatim observations and recurring CFR citations, so your team knows what this site gets cited for.

  • The site's full inspection history, with every Form 483 and its outcome
  • Warning letters and recalls tied to the company behind it
  • Whether recurring CFR citations get closed out or repeat