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Blistex Inc FDA Inspection Record

FEI 1413077 · Inspections, Form 483s, warning letters and import refusals

Blistex Inc is an FDA-inspected facility (FEI 1413077) located in Oak Brook, IL, US. RegDataLab tracks 7 FDA inspections at this facility.

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What FDA found at this site

Latest inspection
May 1, 2025: Voluntary Action Indicated (VAI)
Inspections on record
7 (4 VAI, 3 NAI)
Last OAI inspection
None on record
Warning letters
None matched to this FEI. Many letters do not state an FEI: search warning letters by company name
Recalls as the recalling firm
2, latest Nov 17, 2021
Import refusals
5

A Form 483 lists an inspector's observations. OAI means FDA recommends regulatory and/or administrative action. A warning letter is FDA's formal enforcement notice. No record here does not establish that a site is safe. Check this site on FDA's Data Dashboard.

Inspections and what FDA cited

Newest first. Citations are the inspector observations FDA publishes for the inspection.

DateResultWhat FDA cited
May 1, 2025Voluntary Action Indicated (VAI)Buildings not maintained in good state of repair (21 CFR 211.58)
May 10, 2018No Action Indicated (NAI)No citations listed
Mar 26, 2015No Action Indicated (NAI)No citations listed
Aug 31, 2012Voluntary Action Indicated (VAI)Test methods (21 CFR 211.165(e))
Complaint Investigation/Follow-Up Findings (21 CFR 211.198(b)(2))
Scientifically sound laboratory controls (21 CFR 211.160(b))
May 10, 2011No Action Indicated (NAI)Scientifically sound laboratory controls (21 CFR 211.160(b))
Mar 19, 2010Voluntary Action Indicated (VAI)Investigations of discrepancies, failures (21 CFR 211.192)
Complaint Investigation/Follow-Up Findings (21 CFR 211.198(b)(2))
Scientifically sound laboratory controls (21 CFR 211.160(b))
Written procedures fail to include (21 CFR 211.67(b))
Aug 14, 2009Voluntary Action Indicated (VAI)Written procedures not established/followed (21 CFR 211.67(b))
Investigations of discrepancies, failures (21 CFR 211.192)
Control procedures to monitor and validate performance (21 CFR 211.110(a))
Scientifically sound laboratory controls (21 CFR 211.160(b))
and 1 more

Recalls

Newest first. Recalls FDA's Enforcement Report lists with this FEI as the recalling firm. The recalling firm is not always the site that made the product. Search FDA's Enforcement Report by recall number.

DateClassRecallProduct and reason
Nov 17, 2021Class ID-0159-2024Odor-Eaters Spray Powder, Tolnaftate 1% Antifungal, packaged in a) 4 oz. aerosol cans (UPC…
Chemical contamination: Presence of benzene
Nov 17, 2021Class IIF-1210-2024ODOR-EATERS STINK STOPPERS SPRAY (4 OZ can) UPC 041388006499
benzene contamination

Facility details

Company
Blistex Inc
Location
Oak Brook, IL (US)
Source
inspections

Import refusals

FDA data resources

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.