Mckee Foods Corporation FDA Record

Warning letters, Form 483s, inspections, recalls and 510(k) clearances

Mckee Foods Corporation has 1 FDA recall, 22 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Mckee Foods Corporation" is on file.

What these totals cover: FDA records filed under the name "Mckee Foods Corporation" and its spelling variant "Mckee Foods".

Latest recall
F-1022-2021 · Class II · Sep 10, 2021
Latest inspection
Jun 26, 2026 · NAI

Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls1Nov 8, 2026File dated Nov 3, 2026Current
510(k) clearances0Nov 8, 2026File dated Nov 2, 2026Current
Inspections22Nov 14, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

FDA record by year

Mckee Foods Corporation's FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

Mckee Foods Corporation: FDA inspections per year 2017: 4 inspections420172018: 1 inspections120182019: 0 inspections020192020: 0 inspections020202021: 1 inspections120212022: 1 inspections120222023: 0 inspections020232024: 0 inspections020242025: 2 inspections220252026: 2 inspections22026
YearInspectionsOAIWarning lettersRecall recordsClass I
202620000
202520000
202400000
202300000
202210000
202110010
202000000
201900000
201810000
201740000

Inspections are counted by the date they ended, warning letters by the date FDA issued them and recall records by the recall start date. FDA lists one recall record per recalled product, so one recall event can add several.

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Recent recalls

1 recall record on Sep 10, 2021.

NumberClassProductDate
F-1022-2021Class IILittle Debbie Mini Nutty Buddy Cookie Bites Sandwich Cookies 2.5oz plastic packaging 72 pouches per…Sep 10, 2021

Recent FDA inspections

22 inspections from May 20, 2009 to Jun 26, 2026. Showing the 20 most recent. View all 22 inspections

DateSiteProductClassificationFEI
Jun 26, 2026Grandy, MNFood/CosmeticsNo Action Indicated (NAI)3015902543
May 1, 2026Collegedale, TNFood/CosmeticsNo Action Indicated (NAI)3004344772
Aug 1, 2025Collegedale, TNFood/CosmeticsNo Action Indicated (NAI)1022629
Jul 10, 2025Stuarts Draft, VAFood/CosmeticsNo Action Indicated (NAI)1000123413
Jul 15, 2022Collegedale, TNFood/CosmeticsVoluntary Action Indicated (VAI)1022629
Jul 22, 2021Stuarts Draft, VAFood/CosmeticsNo Action Indicated (NAI)1000123413
Aug 24, 2018Gentry, ARFood/CosmeticsNo Action Indicated (NAI)2314063
Dec 13, 2017Collegedale, TNFood/CosmeticsNo Action Indicated (NAI)1022629
Aug 31, 2017Collegedale, TNFood/CosmeticsNo Action Indicated (NAI)3004344772
Aug 31, 2017Collegedale, TNFood/CosmeticsNo Action Indicated (NAI)3004344472
May 12, 2017Stuarts Draft, VAFood/CosmeticsNo Action Indicated (NAI)1000123413
Apr 2, 2015Gentry, ARFood/CosmeticsNo Action Indicated (NAI)2314063
Jan 21, 2015Collegedale, TNFood/CosmeticsNo Action Indicated (NAI)3004344772
Jan 20, 2015Collegedale, TNFood/CosmeticsNo Action Indicated (NAI)1022629
Dec 9, 2014Stuarts Draft, VAFood/CosmeticsNo Action Indicated (NAI)1000123413
Aug 3, 2012Gentry, ARFood/CosmeticsNo Action Indicated (NAI)2314063
Jun 1, 2012Lexington, KYFood/CosmeticsNo Action Indicated (NAI)3004663788
May 3, 2012Collegedale, TNFood/CosmeticsNo Action Indicated (NAI)3004347092
May 3, 2012Collegedale, TNFood/CosmeticsNo Action Indicated (NAI)3004344772
Sep 22, 2011Collegedale, TNFood/CosmeticsNo Action Indicated (NAI)3004344472
NAI
No objectionable conditions or practices were found during the inspection.
VAI
Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
OAI
Regulatory and/or administrative actions are recommended.

Look up the inspector observations behind these results with the FDA 483 search, or check for formal enforcement with the FDA warning letter search.

FDA-inspected facilities

8 inspected sites, newest inspection first.

FacilityLocationInspectionsLatest
FEI 3015902543Grandy, MN1Jun 26, 2026
FEI 3004344772Collegedale, TN4May 1, 2026
FEI 1022629Collegedale, TN5Aug 1, 2025
FEI 1000123413Stuarts Draft, VA5Jul 10, 2025
FEI 2314063Gentry, AR3Aug 24, 2018
FEI 3004344472Collegedale, TN2Aug 31, 2017
FEI 3004663788Lexington, KY1Jun 1, 2012
FEI 3004347092Collegedale, TN1May 3, 2012

Mckee Foods Corporation and the FDA: common questions

Has Mckee Foods Corporation received an FDA warning letter?

No FDA warning letter addressed to the name "Mckee Foods Corporation" is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.

Has Mckee Foods Corporation received an FDA Form 483?

FDA has not published a Form 483 for "Mckee Foods Corporation" in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Mckee Foods Corporation?

The most recent FDA inspection on file ended Jun 26, 2026 at Grandy, MN and was classified NAI. FDA has 22 inspections of Mckee Foods Corporation on file.

Has Mckee Foods Corporation had an FDA recall?

Yes. Mckee Foods Corporation has 1 FDA recall on record. The most recent started Sep 10, 2021.

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