Atlas

FDA-Inspected Site

OraLabs, Incorporated

14 FDA inspections are on record for OraLabs, Incorporated in Parker, United States.

483· Form 483 issued

Parker, United States · Last updated July 10, 2026

Overview

  • 14 FDA inspections are on record.
  • 8 inspections produced a Form 483.
  • The most recent recorded inspection date is 2025-10-02.

At a glance

Inspections

14

Form 483s

8

EIRs

3

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
22 Sep 2025 – 2 Oct 2025Human DrugsWLView 483 →
6 Jan 2020 – 10 Jan 2020Human Drugs483View 483 →
23 May 2019 – 28 May 2019Medical Devices & Rad Health483View 483 →
9 Jul 2018 – 13 Jul 2018Human Drugs483On file
14 Dec 2015 – 18 Dec 2015Human Drugs483View 483 →
20 Jun 2013 – 26 Jun 2013Human DrugsClean
23 Nov 2011Not recorded483View 483 →
11 Aug 2010Not recorded483View 483 →
22 Sep 2009Not recorded483On file
11 Jan 2008Not recordedClean
28 Nov 2006Not recordedClean
18 May 2004Not recordedClean

Observations on record

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

2 Oct 2025
21 CFR 211.100(a)

Absence of Written Procedures

Cited by Ronda R Loyd Jones, Mercedes N Overton, Stephon D Tillis, Jeffrey T Prosterman

2 Oct 2025
21 CFR 211.110(a)

Control procedures to monitor and validate performance

Cited by Ronda R Loyd Jones, Mercedes N Overton, Stephon D Tillis, Jeffrey T Prosterman

2 Oct 2025
21 CFR 211.160(a)

Following/documenting laboratory controls

Cited by Ronda R Loyd Jones, Mercedes N Overton, Stephon D Tillis, Jeffrey T Prosterman

2 Oct 2025
21 CFR 211.192

Investigations of discrepancies, failures

Cited by Ronda R Loyd Jones, Mercedes N Overton, Stephon D Tillis, Jeffrey T Prosterman

2 Oct 2025
21 CFR 211.67(a)

Cleaning / Sanitizing / Maintenance

Cited by Ronda R Loyd Jones, Mercedes N Overton, Stephon D Tillis, Jeffrey T Prosterman

Investigators

FDA investigators tied to this site in the record.

Jamie L Dion2 insp.
Zachery L Miller2 insp.
State Agency2 insp.
Ronda R Loyd Jones1 insp.
Mercedes N Overton1 insp.
Stephon D Tillis1 insp.
Jeffrey T Prosterman1 insp.
Linda F Murphy1 insp.
Lisa Shin1 insp.
Ian Carrico1 insp.
Matthew M Vernon1 insp.
Tenzin Jangchup1 insp.
Matthew R Dionne1 insp.
Tamara L Setzer1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 820.30(a)Cited across public-safe Form 483 observations4x
21 CFR 211.192Cited across public-safe Form 483 observations3x
21 CFR 211.100(a)Cited across public-safe Form 483 observations2x
21 CFR 211.110(a)Cited across public-safe Form 483 observations2x
21 CFR 211.160(a)Cited across public-safe Form 483 observations2x
21 CFR 211.160(b)Cited across public-safe Form 483 observations2x
21 CFR 211.67(b)Cited across public-safe Form 483 observations2x
21 CFR 803.17Cited across public-safe Form 483 observations2x
21 CFR 211.165(a)Cited across public-safe Form 483 observations1x
21 CFR 211.165(c)Cited across public-safe Form 483 observations1x
21 CFR 211.180(e)(1)Cited across public-safe Form 483 observations1x
21 CFR 211.182Cited across public-safe Form 483 observations1x
21 CFR 211.186(b)(7)Cited across public-safe Form 483 observations1x
21 CFR 211.188Cited across public-safe Form 483 observations1x
21 CFR 211.198(a)Cited across public-safe Form 483 observations1x
21 CFR 211.204Cited across public-safe Form 483 observations1x
21 CFR 211.22(d)Cited across public-safe Form 483 observations1x
21 CFR 211.25(a)Cited across public-safe Form 483 observations1x
21 CFR 211.42(c)(5)Cited across public-safe Form 483 observations1x
21 CFR 211.56(b)Cited across public-safe Form 483 observations1x
21 CFR 211.58Cited across public-safe Form 483 observations1x
21 CFR 211.65(a)Cited across public-safe Form 483 observations1x
21 CFR 211.67(a)Cited across public-safe Form 483 observations1x
21 CFR 211.68(a)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind OraLabs, Incorporated's 8 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