Nikola's Biscotti European Specialties, Co. FDA Record
- Latest inspection NAI · May 16, 2025
- No warning letters matched by name
Nikola's Biscotti European Specialties, Co. has 0 FDA recalls, 6 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Nikola's Biscotti European Specialties, Co." is on file.
- Latest inspection
- May 16, 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 | 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
Nikola's Biscotti European Specialties, Co.: FDA inspections per 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 | 1 | 0 | 0 | 0 | 0 |
| 2021 | 0 | 0 | 0 | 0 | 0 |
| 2020 | 0 | 0 | 0 | 0 | 0 |
| 2019 | 0 | 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 |
|---|---|---|---|---|
| May 16, 2025 | Bloomington, MN | Veterinary | No Action Indicated (NAI) | 3005115163 |
| May 13, 2022 | Bloomington, MN | Food/Cosmetics | Voluntary Action Indicated (VAI) | 3005115163 |
| Nov 9, 2016 | Bloomington, MN | Food/Cosmetics | Voluntary Action Indicated (VAI) | 3005115163 |
| Feb 11, 2016 | Bloomington, MN | Food/Cosmetics | Voluntary Action Indicated (VAI) | 3005115163 |
| Jul 15, 2013 | Bloomington, MN | Food/Cosmetics | Voluntary Action Indicated (VAI) | 3005115163 |
| Dec 30, 2010 | Bloomington, MN | Food/Cosmetics | Voluntary Action Indicated (VAI) | 3005115163 |
- 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 3005115163 | Bloomington, MN | 6 | May 16, 2025 |
Nikola's Biscotti European Specialties, Co. and the FDA: common questions
Has Nikola's Biscotti European Specialties, Co. received an FDA warning letter?
No FDA warning letter addressed to the name "Nikola's Biscotti European Specialties, Co." 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 Nikola's Biscotti European Specialties, Co. received an FDA Form 483?
FDA has not published a Form 483 for "Nikola's Biscotti European Specialties, Co." in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Nikola's Biscotti European Specialties, Co.?
The most recent FDA inspection on file ended May 16, 2025 at Bloomington, MN and was classified NAI. FDA has 6 inspections of Nikola's Biscotti European Specialties, Co. on file.
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