Orion Food Systems, LLC FDA Record
Orion Food Systems, LLC has 0 FDA recalls, 8 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Orion Food Systems, LLC" is on file.
- Latest inspection
- Mar 27, 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 | 8 | 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 | 0 | 0 | 0 | 0 | 0 |
| 2023 | 0 | 0 | 0 | 0 | 0 |
| 2022 | 2 | 0 | 0 | 0 | 0 |
| 2021 | 0 | 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 |
Reviewing Orion Food Systems, LLC as a supplier? Request a free FDA snapshot: name up to five suppliers and get a PDF of their public FDA record, with sources and dates. You do not need an API connection. Each snapshot is prepared by hand.
Or check Orion Food Systems, LLC yourself in Claude, Cursor or ChatGPT: get the full FDA risk summary, with inspections, warning letters, Form 483s and import alerts by site.
Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Mar 27, 2025 | Sioux Falls, SD | Food/Cosmetics | No Action Indicated (NAI) | 1000116375 |
| Jun 22, 2022 | Kimball, TN | Food/Cosmetics | No Action Indicated (NAI) | 3004395229 |
| Mar 25, 2022 | Sioux Falls, SD | Food/Cosmetics | Voluntary Action Indicated (VAI) | 1000116375 |
| Feb 28, 2018 | Sioux Falls, SD | Food/Cosmetics | No Action Indicated (NAI) | 1000116375 |
| Feb 20, 2015 | Sioux Falls, SD | Food/Cosmetics | No Action Indicated (NAI) | 1000116375 |
| Mar 22, 2012 | Sioux Falls, SD | Food/Cosmetics | No Action Indicated (NAI) | 1000116375 |
| Apr 19, 2010 | Sioux Falls, SD | Food/Cosmetics | No Action Indicated (NAI) | 1000116375 |
| Jul 20, 2009 | Sioux Falls, SD | Food/Cosmetics | No Action Indicated (NAI) | 1000116375 |
- 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 1000116375 | Sioux Falls, SD | 7 | Mar 27, 2025 |
| FEI 3004395229 | Kimball, TN | 1 | Jun 22, 2022 |
Orion Food Systems, LLC and the FDA: common questions
Has Orion Food Systems, LLC received an FDA warning letter?
No FDA warning letter addressed to the name "Orion Food Systems, LLC" 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 Orion Food Systems, LLC received an FDA Form 483?
FDA has not published a Form 483 for "Orion Food Systems, LLC" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Orion Food Systems, LLC?
The most recent FDA inspection on file ended Mar 27, 2025 at Sioux Falls, SD and was classified NAI. FDA has 8 inspections of Orion Food Systems, LLC on file.
Need more than this page shows? Ask about Orion Food Systems, LLC in Claude or ChatGPT and get every site's inspections, Form 483s, warning letters and import alerts, with a link to the FDA source for each record. The API key is free: no card.