FDA-Inspected Site

Blistex Inc

10 FDA inspections are on record for Blistex Inc in Oak Brook, United States.

483· Form 483 issued

Oak Brook, United States · Last updated July 10, 2026

Overview

  • 10 FDA inspections are on record.
  • 5 inspections produced a Form 483.
  • The most recent recorded inspection date is 2025-05-01.

At a glance

Inspections

10

Form 483s

5

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
29 Apr 2025 – 1 May 2025Human Drugs483View 483 →
7 May 2018 – 10 May 2018Human DrugsClean
19 Mar 2015 – 26 Mar 2015Human DrugsClean
31 Aug 2012Not recorded483On file
10 May 2011Not recorded483View 483 →
19 Mar 2010Not recorded483On file
14 Aug 2009Not recorded483View 483 →
20 Jun 2007Not recordedClean
15 Dec 2004Not recordedClean
14 Sep 2001Not recordedClean

Observations on record

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

1 May 2025
21 CFR 211.58

Buildings not maintained in good state of repair

Cited by Tyler M Peterson, Ramia Brzenjy, Angela C Welker

10 May 2011
21 CFR 211.160(b)

Scientifically sound laboratory controls

Cited by Nicholas P Diorio

14 Aug 2009
21 CFR 211.67(b)

Written procedures not established/followed

Cited by Carrie-Ann Plucinski

14 Aug 2009
21 CFR 211.110(a)

Control procedures to monitor and validate performance

Cited by Carrie-Ann Plucinski

14 Aug 2009
21 CFR 211.160(b)

Scientifically sound laboratory controls

Cited by Carrie-Ann Plucinski

Investigators

FDA investigators tied to this site in the record.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 211.160(b)Cited across public-safe Form 483 observations2x
21 CFR 211.110(a)Cited across public-safe Form 483 observations1x
21 CFR 211.192Cited across public-safe Form 483 observations1x
21 CFR 211.198(b)(2)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

Full site report

Get the verbatim findings behind Blistex Inc's 5 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