Kutol Products Company, Inc.
FDA Regulatory Profile
Kutol Products Company, Inc. has 1 FDA recall, 6 inspections, 0 510(k) clearances and 0 compliance actions on record.
- Latest recall
- D-1387-2012 · Class II · May 21, 2012
- Latest inspection
- Mar 4, 2025 · OAI
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Summary
Record counts and when each FDA source was last refreshed
| Records | Count | Last refreshed | Source as of | Status |
|---|
| Recalls | 1 | Nov 4, 2026 (checked Nov 8, 2026, unchanged) | File dated Nov 3, 2026 | Current |
|---|
| 510(k) clearances | 0 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
|---|
| Inspections | 6 | Nov 8, 2026 | Newest record Oct 28, 2026 | Current |
|---|
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
|---|
Recent Recalls
| Number | Class | Product | Date |
|---|
| D-1387-2012 | Class II | Hands Down Medicated Lotion Soap, 1 gallon bottle, 4 gallons per case, Distributed by PCS… | May 21, 2012 |
Recent FDA Inspections
| Date | Site | Product | Classification | FEI |
|---|
| Mar 4, 2025 | Sharonville, OH | Drugs | Official Action Indicated (OAI) | 1513988 |
| Mar 3, 2020 | Sharonville, OH | Drugs | Voluntary Action Indicated (VAI) | 1513988 |
| Sep 29, 2015 | Sharonville, OH | Food/Cosmetics | Voluntary Action Indicated (VAI) | 1513988 |
| Jan 2, 2014 | Sharonville, OH | Drugs | Voluntary Action Indicated (VAI) | 1513988 |
| Oct 11, 2012 | Sharonville, OH | Drugs | Voluntary Action Indicated (VAI) | 1513988 |
| Apr 9, 2010 | Sharonville, OH | Drugs | Voluntary Action Indicated (VAI) | 1513988 |
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 1513988 | Sharonville, OH | 6 | Mar 4, 2025 |