Smithfield Direct LLC

FDA Regulatory Profile

Smithfield Direct LLC has 0 FDA recalls, 9 inspections, 0 510(k) clearances and 0 compliance actions on record.

What these totals cover: FDA records filed under the name "Smithfield Direct LLC" and its spelling variant "Smithfield Direct".

Latest inspection
Jan 7, 2026 · NAI

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Nov 8, 2026File dated Nov 3, 2026Current
510(k) clearances0Nov 8, 2026File dated Nov 2, 2026Current
Inspections9Nov 13, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

FDA record by year

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

Smithfield Direct LLC: FDA inspections per year 2017: 0 inspections020172018: 0 inspections020182019: 2 inspections220192020: 0 inspections020202021: 0 inspections020212022: 0 inspections020222023: 1 inspections120232024: 1 inspections120242025: 0 inspections020252026: 1 inspections12026
YearInspectionsOAIWarning lettersRecall recordsClass I
202610000
202500000
202410000
202310000
202200000
202100000
202000000
201920000
201800000
201700000

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.

Recent FDA inspections

9 inspections from Dec 21, 2010 to Jan 7, 2026.

DateSiteProductClassificationFEI
Jan 7, 2026South Bend, INFood/CosmeticsNo Action Indicated (NAI)2000031191
Jul 17, 2024Houston, TXFood/CosmeticsNo Action Indicated (NAI)2000027350
Jul 27, 2023Warrendale, PAFood/CosmeticsNo Action Indicated (NAI)3013238618
Jun 19, 2019Louisville, KYFood/CosmeticsNo Action Indicated (NAI)2000031196
Jun 3, 2019San Antonio, TXFood/CosmeticsNo Action Indicated (NAI)2000031249
Jul 8, 2015South Bend, INFood/CosmeticsNo Action Indicated (NAI)2000031191
Oct 22, 2014Houston, TXFood/CosmeticsNo Action Indicated (NAI)2000027350
Jul 26, 2012Houston, TXFood/CosmeticsNo Action Indicated (NAI)2000027350
Dec 21, 2010Mesquite, TXFood/CosmeticsNo Action Indicated (NAI)2000031245
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

6 inspected sites, newest inspection first.

FacilityLocationInspectionsLatest
FEI 2000031191South Bend, IN2Jan 7, 2026
FEI 2000027350Houston, TX3Jul 17, 2024
FEI 3013238618Warrendale, PA1Jul 27, 2023
FEI 2000031196Louisville, KY1Jun 19, 2019
FEI 2000031249San Antonio, TX1Jun 3, 2019
FEI 2000031245Mesquite, TX1Dec 21, 2010

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