Karlsburger Foods, Inc. FDA Inspection Record

FEI 2122542 · Inspections, Form 483s, warning letters and import refusals

Karlsburger Foods, Inc. is an FDA-inspected facility (FEI 2122542) located in Monticello, MN, US. RegDataLab tracks 8 FDA inspections and 1 compliance action at this facility.

What FDA found at this site

Latest inspection
Apr 1, 2025: Voluntary Action Indicated (VAI)
Inspections on record
8 (1 OAI, 6 VAI, 1 NAI)
Last OAI inspection
Jul 19, 2010
Warning letters
1 listed by FDA for this FEI, latest Dec 16, 2010
Recalls as the recalling firm
5, latest Sep 19, 2022

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
Apr 1, 2025Voluntary Action Indicated (VAI)Sanitation monitoring (21 CFR 123.11(b))
Plant operations - Precautions (21 CFR 117.80(a))
HACCP plan location (21 CFR 123.6(b))
Jan 25, 2024No Action Indicated (NAI)No citations listed
Aug 17, 2022Voluntary Action Indicated (VAI)Personnel (21 CFR 117.10)
Process preventive controls - Implement (21 CFR 117.135(a)(1))
Hazard analysis - Identification of hazard (21 CFR 117.130(a)(1))
Process preventive controls - Appropriate (Adequate) (21 CFR 117.135(c)(1))
Aug 23, 2019Voluntary Action Indicated (VAI)Sanitary operations - Plant sanitation (21 CFR 117.35(a))
Sanitary facilities and controls (21 CFR 117.37)
Equipment and utensils - Design and maintenance (21 CFR 117.40)
Nov 20, 2014Voluntary Action Indicated (VAI)No citations listed
May 27, 2011Voluntary Action Indicated (VAI)Sanitation monitoring (21 CFR 123.11(b))
Monitoring - adequacy (21 CFR 123.6(c)(4))
Verification - record review - frequency (21 CFR 123.8(a)(3))
Verification - reviewers qualifications (21 CFR 123.8(a))
and 2 more
Jul 19, 2010Official Action Indicated (OAI)Sanitation monitoring (21 CFR 123.11(b))
Food safety hazards (21 CFR 123.6(c)(1))
Critical control points (21 CFR 123.6(c)(2))
Corrective action plan (21 CFR 123.6(c)(5))
Aug 6, 2009Voluntary Action Indicated (VAI)Cleaning and sanitizing operations (21 CFR 110.35(a))
Reasonable precautions (21 CFR 110.80)
Sanitation monitoring documentation (21 CFR 123.11(b))
Verification procedures - none/frequency (21 CFR 123.6(c)(6))
and 5 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
Sep 19, 2022Class IIIF-0049-2023Karlsburger Kitchens NSLP 140 Beef Gravy Mix, Gluten Free. Packaged in the following… and 1 more product
undeclared non-wheat gluten, product labeled gluten-free
Oct 19, 2018Class IIF-0340-2019Karlsburger Kitchens Roasted Onion Base, item # 23650, Net Weight 50 lbs (22.68 kg), UPC…
Firm is recalling a Roasted Onion Base product due to potential Listeria monocytogenes and Salmonella contamination.
May 10, 2016Class IIF-1423-2016Karlsburger, Mesquite Seasoning Mix & Marinade, Item 46402, Net WT 2 lbs in plastic shaker…
Karlsburger Foods Inc., is recalling 2 lb containers of Mesquite Seasoning Mix because it contains an undeclared allergen, soy. Product…
Nov 17, 2014Class IF-0572-2015Karlsburger Foods Taco Seasoning, Item Numbers 43823 (Packaged in 23 oz resealable plastic… and 1 more product
Taco Seasoning has an allergen of milk in the product that is not declared on the label.
Nov 10, 2014Class IF-0512-2015InHarvest Garden Vegetable Seasoning, Item 61104, Net Wt 4 oz.
Firm is recalling Garden Vegetable Seasoning due to an undeclared milk allergen.

FDA record score

12 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.

12 records behind this number
RecordDatePoints x age weightAdds
Inspection classified VAIApr 1, 20256 x 16
Inspection classified VAIAug 17, 20226 x 0.63.6
Inspection classified VAIAug 23, 20196 x 0.251.5
Class II recall F-0340-2019, this FEI as the recalling firmOct 19, 20184 x 0.251
Class II recall F-1423-2016, this FEI as the recalling firmMay 10, 201610 years or older, so it adds no points0
Inspection classified VAINov 20, 201410 years or older, so it adds no points0
Class I recall F-0572-2015, this FEI as the recalling firmNov 17, 201410 years or older, so it adds no points0
Class I recall F-0512-2015, this FEI as the recalling firmNov 10, 201410 years or older, so it adds no points0
Inspection classified VAIMay 27, 201110 years or older, so it adds no points0
Warning letter on FDA's dashboard, which does not show close-outsDec 16, 201010 years or older, so it adds no points0
Inspection classified OAIJul 19, 201010 years or older, so it adds no points0
Inspection classified VAIAug 6, 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
Karlsburger Foods, Inc.
Location
Monticello, MN (US)
Source
inspections

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