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Fruit Of The Earth, Inc. FDA Inspection Record

FEI 1420298 · Inspections, Form 483s, warning letters and import refusals

Fruit Of The Earth, Inc. is an FDA-inspected facility (FEI 1420298) located in Grand Prairie, TX, US. RegDataLab tracks 9 FDA inspections at this facility.

What FDA found at this site

Latest inspection
Dec 18, 2025: No Action Indicated (NAI)
Inspections on record
9 (1 OAI, 6 VAI, 2 NAI)
Last OAI inspection
Jan 3, 2012
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
1, latest Mar 11, 2025

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
Dec 18, 2025No Action Indicated (NAI)No citations listed
Apr 14, 2023No Action Indicated (NAI)No citations listed
Mar 31, 2023Voluntary Action Indicated (VAI)Buildings not maintained in good state of repair (21 CFR 211.58)
Dec 22, 2021Voluntary Action Indicated (VAI)Specifications - identity, purity, strength, composition (21 CFR 111.70(e))
Tests, examinations - scientifically valid (21 CFR 111.75(h))
Manufacturing, processing, packing, holding - Controls (21 CFR 117.80(c))
Scheduled process establishment (21 CFR 114.83)
and 2 more
Apr 13, 2017Voluntary Action Indicated (VAI)Authority lacking to review records, investigate errors (21 CFR 211.22(a))
Written procedures not established/followed (21 CFR 211.67(b))
SOPs not followed / documented (21 CFR 211.100(b))
Microbiological testing (21 CFR 211.165(b))
Mar 3, 2015Voluntary Action Indicated (VAI)Scheduled process establishment (21 CFR 114.83)
Registration (21 CFR 108.25(c)(1))
Process filing (21 CFR 108.25(c)(2))
Jan 30, 2014Voluntary Action Indicated (VAI)Authority lacking to review records, investigate errors (21 CFR 211.22(a))
Cleaning / Sanitizing / Maintenance (21 CFR 211.67(a))
Absence of Written Procedures (21 CFR 211.100(a))
Reprocessing procedures not written or followed (21 CFR 211.115(a))
and 7 more
Jan 3, 2012Official Action Indicated (OAI)Training , Education , Experience overall (21 CFR 211.25(a))
Cleaning / Sanitizing / Maintenance (21 CFR 211.67(a))
Absence of Written Procedures (21 CFR 211.100(a))
Master manufacturing record - Supplemental Facts (21 CFR 111.210(d))
and 12 more
May 29, 2009Voluntary Action Indicated (VAI)Procedures not in writing, fully followed (21 CFR 211.22(d))
Training--operations, GMPs, written procedures (21 CFR 211.25(a))
SOPs not followed / documented (21 CFR 211.100(b))
Reprocessing procedures not written or followed (21 CFR 211.115(a))
and 8 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
Mar 11, 2025Class IID-0283-2025Walgreens Maximum Strength Tinted Acne Treatment Cream 10% Benzoyl Peroxide/Acne… and 1 more product
Chemical contamination: presence of benzene

FDA record score

13 of 100. A count of this site's adverse public FDA records, weighted by how recent each one is. A higher number means more, or more recent, records. Each record below adds the points shown.

Counted on Nov 14, 2026, method version 1. It counts records and does not judge the site: a low number does not establish that a site is safe, and sites that FDA inspects more often can collect more points. How this is counted.

8 records behind this number
RecordDatePoints x age weightAdds
Class II recall D-0283-2025, this FEI as the recalling firmMar 11, 20254 x 14
Inspection classified VAIMar 31, 20236 x 0.63.6
Inspection classified VAIDec 22, 20216 x 0.63.6
Inspection classified VAIApr 13, 20176 x 0.251.5
Inspection classified VAIMar 3, 201510 years or older, so it adds no points0
Inspection classified VAIJan 30, 201410 years or older, so it adds no points0
Inspection classified OAIJan 3, 201210 years or older, so it adds no points0
Inspection classified VAIMay 29, 200910 years or older, so it adds no points0

When each source was last refreshed

FDA sources behind this page and when RegDataLab last refreshed each one
RecordsLast refreshedSource as ofStatus
InspectionsNov 14, 2026Newest record Nov 5, 2026Current
Inspection citationsNov 14, 2026Newest record Nov 5, 2026Current
Compliance actions (warning letters, injunctions and other action types)Nov 2, 2026Newest record Oct 29, 2026Current
Warning letter textNov 14, 2026Newest record Nov 10, 2026Current
Recalls (Enforcement Report)Nov 14, 2026Newest record Nov 11, 2026Current
Form 483s and inspection documentsNov 13, 2026Newest record Nov 12, 2026Current
Import refusalsNov 2, 2026Newest record Oct 22, 2026Current

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Facility details

Company
Fruit Of The Earth, Inc.
Location
Grand Prairie, TX (US)
Source
inspections

FDA data resources

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