Hawthorne Products, Inc.
FDA Regulatory Profile
Hawthorne Products, Inc. has 0 FDA recalls, 5 inspections, 1 510(k) clearance and 0 compliance actions on record.
- Latest inspection
- May 21, 2025 · VAI
- Latest 510(k)
- Dec 31, 1990
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Summary
Record counts and when each FDA source was last refreshed
| Records | Count | Last refreshed | Source as of | Status |
|---|
| Recalls | 0 | Nov 8, 2026 | File dated Nov 3, 2026 | Current |
|---|
| 510(k) clearances | 1 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
|---|
| Inspections | 5 | Nov 11, 2026 | Newest record Nov 5, 2026 | Current |
|---|
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
|---|
Recent FDA Inspections
| Date | Site | Product | Classification | FEI |
|---|
| May 21, 2025 | Dunkirk, IN | Veterinary | Voluntary Action Indicated (VAI) | 1824900 |
| Aug 11, 2017 | Dunkirk, IN | Veterinary | Voluntary Action Indicated (VAI) | 1824900 |
| Nov 19, 2013 | Dunkirk, IN | Veterinary | Voluntary Action Indicated (VAI) | 1824900 |
| Jan 25, 2012 | Dunkirk, IN | Veterinary | Voluntary Action Indicated (VAI) | 1824900 |
| Aug 17, 2009 | Dunkirk, IN | Veterinary | Voluntary Action Indicated (VAI) | 1824900 |
NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.
FDA-Inspected Facilities
| Facility | Location | Inspections | Latest |
|---|
| FEI 1824900 | Dunkirk, IN | 5 | May 21, 2025 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K903946 | COOL CAST(R) | Dec 31, 1990 |