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Heinen's Inc.

FDA Regulatory Profile

Heinen's Inc. has 0 FDA recalls, 4 inspections, 0 510(k) clearances and 0 compliance actions on record.

What these totals cover: FDA records filed under the name "Heinen's Inc." and its spelling variant "Heinen".

Latest inspection
Sep 24, 2024 · 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
Inspections4Nov 13, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

FDA record by year

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

Heinen's Inc.: FDA inspections per year 2017: 0 inspections020172018: 0 inspections020182019: 0 inspections020192020: 0 inspections020202021: 0 inspections020212022: 1 inspections120222023: 1 inspections120232024: 2 inspections220242025: 0 inspections020252026: 0 inspections02026
YearInspectionsOAIWarning lettersRecall recordsClass I
202600000
202500000
202420000
202310000
202210000
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202000000
201900000
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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

4 inspections from May 19, 2022 to Sep 24, 2024.

DateSiteProductClassificationFEI
Sep 24, 2024Warrensville Heights, OHFood/CosmeticsNo Action Indicated (NAI)3007315037
Jun 17, 2024Cleveland, OHFood/CosmeticsNo Action Indicated (NAI)3014668932
Jul 26, 2023Cleveland, OHFood/CosmeticsNo Action Indicated (NAI)3014668932
May 19, 2022Warrensville Heights, OHFood/CosmeticsVoluntary Action Indicated (VAI)3007315037
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

2 inspected sites, newest inspection first.

FacilityLocationInspectionsLatest
FEI 3007315037Warrensville Heights, OH2Sep 24, 2024
FEI 3014668932Cleveland, OH2Jun 17, 2024

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FDA data resources

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