Ornua Ingredients North America FDA Record
- Latest inspection NAI · Aug 1, 2023
- No warning letters matched by name
Ornua Ingredients North America has 0 FDA recalls, 6 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Ornua Ingredients North America" is on file.
- Latest inspection
- Aug 1, 2023 · 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 | 6 | 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
Ornua Ingredients North America: FDA inspections per year
| Year | Inspections | OAI | Warning letters | Recall records | Class I |
|---|---|---|---|---|---|
| 2026 | 0 | 0 | 0 | 0 | 0 |
| 2025 | 0 | 0 | 0 | 0 | 0 |
| 2024 | 0 | 0 | 0 | 0 | 0 |
| 2023 | 1 | 0 | 0 | 0 | 0 |
| 2022 | 0 | 0 | 0 | 0 | 0 |
| 2021 | 1 | 0 | 0 | 0 | 0 |
| 2020 | 0 | 0 | 0 | 0 | 0 |
| 2019 | 0 | 0 | 0 | 0 | 0 |
| 2018 | 1 | 0 | 0 | 0 | 0 |
| 2017 | 0 | 0 | 0 | 0 | 0 |
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Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Aug 1, 2023 | Byron, MN | Food/Cosmetics | No Action Indicated (NAI) | 3007218735 |
| Oct 21, 2021 | Slippery Rock, PA | Food/Cosmetics | No Action Indicated (NAI) | 3013162657 |
| Jan 24, 2018 | Byron, MN | Food/Cosmetics | No Action Indicated (NAI) | 3007218735 |
| Dec 13, 2016 | Slippery Rock, PA | Food/Cosmetics | No Action Indicated (NAI) | 3013162657 |
| Aug 24, 2015 | Byron, MN | Food/Cosmetics | No Action Indicated (NAI) | 3007218735 |
| May 17, 2011 | Byron, MN | Food/Cosmetics | No Action Indicated (NAI) | 3007218735 |
- 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 3007218735 | Byron, MN | 4 | Aug 1, 2023 |
| FEI 3013162657 | Slippery Rock, PA | 2 | Oct 21, 2021 |
Ornua Ingredients North America and the FDA: common questions
Has Ornua Ingredients North America received an FDA warning letter?
No FDA warning letter addressed to the name "Ornua Ingredients North America" 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 Ornua Ingredients North America received an FDA Form 483?
FDA has not published a Form 483 for "Ornua Ingredients North America" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Ornua Ingredients North America?
The most recent FDA inspection on file ended Aug 1, 2023 at Byron, MN and was classified NAI. FDA has 6 inspections of Ornua Ingredients North America on file.
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