Orange Bakery, Inc. FDA Record

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

Orange Bakery, Inc. has 0 FDA recalls, 13 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Orange Bakery, Inc." is on file.

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

Latest inspection
Apr 24, 2025 · NAI

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
Inspections13Nov 14, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

FDA record by year

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

Orange Bakery, Inc.: FDA inspections per year 2017: 0 inspections020172018: 0 inspections020182019: 2 inspections220192020: 0 inspections020202021: 1 inspections120212022: 0 inspections020222023: 2 inspections220232024: 1 inspections120242025: 1 inspections120252026: 0 inspections02026
YearInspectionsOAIWarning lettersRecall recordsClass I
202600000
202510000
202410000
202320000
202200000
202110000
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.

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Recent FDA inspections

13 inspections from May 27, 2010 to Apr 24, 2025.

DateSiteProductClassificationFEI
Apr 24, 2025Irvine, CAFood/CosmeticsNo Action Indicated (NAI)2023661
Dec 4, 2024Irvine, CAFood/CosmeticsNo Action Indicated (NAI)3004398010
Dec 20, 2023Irvine, CAFood/CosmeticsNo Action Indicated (NAI)3003569226
May 18, 2023Huntersville, NCFood/CosmeticsVoluntary Action Indicated (VAI)1051846
Mar 25, 2021Irvine, CAFood/CosmeticsNo Action Indicated (NAI)3003569226
Aug 14, 2019Irvine, CAFood/CosmeticsNo Action Indicated (NAI)3004398010
Jul 17, 2019Irvine, CAFood/CosmeticsVoluntary Action Indicated (VAI)2023661
Sep 22, 2016Irvine, CAFood/CosmeticsVoluntary Action Indicated (VAI)3004398010
Aug 25, 2016Irvine, CAFood/CosmeticsVoluntary Action Indicated (VAI)2023661
Jan 19, 2012Irvine, CAFood/CosmeticsNo Action Indicated (NAI)3003569226
Jan 31, 2011Irvine, CAFood/CosmeticsVoluntary Action Indicated (VAI)2023661
Oct 6, 2010Irvine, CAFood/CosmeticsNo Action Indicated (NAI)3004398010
May 27, 2010Irvine, CAFood/CosmeticsVoluntary Action Indicated (VAI)2023661
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

4 inspected sites, newest inspection first.

FacilityLocationInspectionsLatest
FEI 2023661Irvine, CA5Apr 24, 2025
FEI 3004398010Irvine, CA4Dec 4, 2024
FEI 3003569226Irvine, CA3Dec 20, 2023
FEI 1051846Huntersville, NC1May 18, 2023

Orange Bakery, Inc. and the FDA: common questions

Has Orange Bakery, Inc. received an FDA warning letter?

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

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

When did the FDA last inspect Orange Bakery, Inc.?

The most recent FDA inspection on file ended Apr 24, 2025 at Irvine, CA and was classified NAI. FDA has 13 inspections of Orange Bakery, Inc. on file.

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