Gina Marie Bakery LLC

FDA Regulatory Profile

Gina Marie Bakery LLC has 7 FDA recalls, 1 inspection, 0 510(k) clearances and 0 compliance actions on record.

What these totals cover: FDA records filed under the name "Gina Marie Bakery LLC" and its spelling variant "Gina Marie Bakery".

Latest recall
H-0004-2026 · Class II · Sep 10, 2025
Latest inspection
Dec 1, 2025 · VAI

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls7Nov 8, 2026File dated Nov 3, 2026Current
510(k) clearances0Nov 8, 2026File dated Nov 2, 2026Current
Inspections1Nov 14, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

Recent recalls

7 recall records on Sep 10, 2025.

NumberClassProductDate
H-0004-2026Class IIItalian Sesame CookiesSep 10, 2025
H-0003-2026Class IIItalian Mixed Vanilla CookiesSep 10, 2025
H-0009-2026Class IIIToasted Cherry BiscottiSep 10, 2025
H-0008-2026Class IIVanilla Cookies with Raspberry Peach JamSep 10, 2025
H-0006-2026Class IIVanilla with Apricot Jam CookiesSep 10, 2025
H-0007-2026Class IIIToasted Almond & Cherry BiscottiSep 10, 2025
H-0005-2026Class IIIVanilla Chocolate Dipped CookiesSep 10, 2025

Recent FDA inspections

1 inspection on Dec 1, 2025.

DateSiteProductClassificationFEI
Dec 1, 2025Waterbury, CTFood/CosmeticsVoluntary Action Indicated (VAI)3040097718
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

1 inspected site, newest inspection first.

FacilityLocationInspectionsLatest
FEI 3040097718Waterbury, CT1Dec 1, 2025

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