Orange Bakery, Inc. FDA Record
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.
- Latest inspection
- Apr 24, 2025 · NAI
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Nov 8, 2026 | File dated Nov 3, 2026 | Current |
| 510(k) clearances | 0 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
| Inspections | 13 | Nov 14, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
FDA record by year
| Year | Inspections | OAI | Warning letters | Recall records | Class I |
|---|---|---|---|---|---|
| 2026 | 0 | 0 | 0 | 0 | 0 |
| 2025 | 1 | 0 | 0 | 0 | 0 |
| 2024 | 1 | 0 | 0 | 0 | 0 |
| 2023 | 2 | 0 | 0 | 0 | 0 |
| 2022 | 0 | 0 | 0 | 0 | 0 |
| 2021 | 1 | 0 | 0 | 0 | 0 |
| 2020 | 0 | 0 | 0 | 0 | 0 |
| 2019 | 2 | 0 | 0 | 0 | 0 |
| 2018 | 0 | 0 | 0 | 0 | 0 |
| 2017 | 0 | 0 | 0 | 0 | 0 |
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Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Apr 24, 2025 | Irvine, CA | Food/Cosmetics | No Action Indicated (NAI) | 2023661 |
| Dec 4, 2024 | Irvine, CA | Food/Cosmetics | No Action Indicated (NAI) | 3004398010 |
| Dec 20, 2023 | Irvine, CA | Food/Cosmetics | No Action Indicated (NAI) | 3003569226 |
| May 18, 2023 | Huntersville, NC | Food/Cosmetics | Voluntary Action Indicated (VAI) | 1051846 |
| Mar 25, 2021 | Irvine, CA | Food/Cosmetics | No Action Indicated (NAI) | 3003569226 |
| Aug 14, 2019 | Irvine, CA | Food/Cosmetics | No Action Indicated (NAI) | 3004398010 |
| Jul 17, 2019 | Irvine, CA | Food/Cosmetics | Voluntary Action Indicated (VAI) | 2023661 |
| Sep 22, 2016 | Irvine, CA | Food/Cosmetics | Voluntary Action Indicated (VAI) | 3004398010 |
| Aug 25, 2016 | Irvine, CA | Food/Cosmetics | Voluntary Action Indicated (VAI) | 2023661 |
| Jan 19, 2012 | Irvine, CA | Food/Cosmetics | No Action Indicated (NAI) | 3003569226 |
| Jan 31, 2011 | Irvine, CA | Food/Cosmetics | Voluntary Action Indicated (VAI) | 2023661 |
| Oct 6, 2010 | Irvine, CA | Food/Cosmetics | No Action Indicated (NAI) | 3004398010 |
| May 27, 2010 | Irvine, CA | Food/Cosmetics | Voluntary 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.
FDA-inspected facilities
| Facility | Location | Inspections | Latest |
|---|---|---|---|
| FEI 2023661 | Irvine, CA | 5 | Apr 24, 2025 |
| FEI 3004398010 | Irvine, CA | 4 | Dec 4, 2024 |
| FEI 3003569226 | Irvine, CA | 3 | Dec 20, 2023 |
| FEI 1051846 | Huntersville, NC | 1 | May 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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