Atlas

FDA-Inspected Site

Ultradent Products, Inc.

9 FDA inspections are on record for Ultradent Products, Inc. in South Jordan, United States.

483· Form 483 issued

South Jordan, United States · Last updated July 9, 2026

Overview

  • 9 FDA inspections are on record.
  • 6 inspections produced a Form 483.
  • The most recent recorded inspection date is 2025-06-13.

At a glance

Inspections

9

Form 483s

6

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
9 Jun 2025 – 13 Jun 2025Human Drugs483View 483 →
13 Jan 2020 – 17 Jan 2020Human Drugs483View 483 →
28 Mar 2019Medical Devices & Rad HealthClean
11 Sep 2017 – 15 Sep 2017Human Drugs483View 483 →
9 Sep 2014 – 12 Sep 2014Medical Devices & Rad HealthWLView 483 →
4 Nov 2013 – 8 Nov 2013Medical Devices & Rad Health483View 483 →
15 Jan 2010Not recorded483View 483 →
16 Apr 2008Not recordedClean
20 Jun 2006Not recordedClean

Observations on record

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

13 Jun 2025
21 CFR 211.160(b)

Scientifically sound laboratory controls

Cited by Ronda R Loyd Jones, Michael Z Weigman, Jeffrey T Prosterman

13 Jun 2025
21 CFR 211.192

No written record of investigation

Cited by Ronda R Loyd Jones, Michael Z Weigman, Jeffrey T Prosterman

13 Jun 2025
21 CFR 211.67(b)

Written procedures not established/followed

Cited by Ronda R Loyd Jones, Michael Z Weigman, Jeffrey T Prosterman

17 Jan 2020
21 CFR 211.160(a)

Following/documenting laboratory controls

Cited by Nayan J Patel

17 Jan 2020
21 CFR 211.160(b)

Scientifically sound laboratory controls

Cited by Nayan J Patel

Investigators

FDA investigators tied to this site in the record.

Ronda R Loyd Jones1 insp.
Michael Z Weigman1 insp.
Jeffrey T Prosterman1 insp.
Nayan J Patel1 insp.
Christine I Shaw1 insp.
Haroon Vohra1 insp.
Michael A Charles1 insp.
Janet Pulver1 insp.
Nathan R Moon1 insp.
Matthew R Dionne1 insp.
Ginger M Sykes1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 211.192Cited across public-safe Form 483 observations3x
21 CFR 211.160(b)Cited across public-safe Form 483 observations2x
21 CFR 820.198(a)Cited across public-safe Form 483 observations2x
21 CFR 820.198(c)Cited across public-safe Form 483 observations2x
21 CFR 820.30(c)Cited across public-safe Form 483 observations2x
21 CFR 211.110(a)Cited across public-safe Form 483 observations1x
21 CFR 211.160(a)Cited across public-safe Form 483 observations1x
21 CFR 211.165(e)Cited across public-safe Form 483 observations1x
21 CFR 211.58Cited across public-safe Form 483 observations1x
21 CFR 211.67(b)Cited across public-safe Form 483 observations1x
21 CFR 820.100(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 820.30(j)Cited across public-safe Form 483 observations1x
21 CFR 820.75(b)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Ultradent Products, Inc.'s 6 Form 483s

Source PDFs, 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