Harvest Bakery Inc FDA Record

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

Harvest Bakery Inc has 0 FDA recalls, 4 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Harvest Bakery Inc" is on file.

What these totals cover: FDA records filed under the name "Harvest Bakery Inc" and its spelling variant "Harvest Bakery".

Latest inspection
Mar 14, 2025 · VAI

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 14, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

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Recent FDA inspections

4 inspections from Dec 1, 2010 to Mar 14, 2025.

DateSiteProductClassificationFEI
Mar 14, 2025Holtsville, NYFood/CosmeticsVoluntary Action Indicated (VAI)2000035562
Jan 10, 2012Bristol, CTFood/CosmeticsNo Action Indicated (NAI)1281416
Jan 11, 2011Holtsville, NYFood/CosmeticsNo Action Indicated (NAI)2000035562
Dec 1, 2010Bristol, CTFood/CosmeticsNo Action Indicated (NAI)1281416
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 2000035562Holtsville, NY2Mar 14, 2025
FEI 1281416Bristol, CT2Jan 10, 2012

Harvest Bakery Inc and the FDA: common questions

Has Harvest Bakery Inc received an FDA warning letter?

No FDA warning letter addressed to the name "Harvest Bakery Inc" 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 Harvest Bakery Inc received an FDA Form 483?

FDA has not published a Form 483 for "Harvest Bakery Inc" in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Harvest Bakery Inc?

The most recent FDA inspection on file ended Mar 14, 2025 at Holtsville, NY and was classified VAI. FDA has 4 inspections of Harvest Bakery Inc on file.

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