Private Label Partners, Inc.
FDA Regulatory Profile
Private Label Partners, Inc. has 1 FDA recall, 6 inspections, 0 510(k) clearances and 1 compliance action on record.
- Latest recall
- D-0152-2024 · Class II · Dec 13, 2023
- Latest inspection
- Jan 17, 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 | 1 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
|---|
Recent Recalls
| Number | Class | Product | Date |
|---|
| D-0152-2024 | Class II | Selenium Sulfide 2.25% Shampoo, 180mL bottle, Rx Only, Manufactured for: Bi-Coastal Pharma Int. LLC… | Dec 13, 2023 |
Recent FDA Inspections
| Date | Site | Product | Classification | FEI |
|---|
| Jan 17, 2025 | Santa Ana, CA | Drugs | Official Action Indicated (OAI) | 3003350069 |
| Sep 13, 2019 | Santa Ana, CA | Drugs | Voluntary Action Indicated (VAI) | 3003350069 |
| Jun 17, 2016 | Santa Ana, CA | Drugs | Voluntary Action Indicated (VAI) | 3003350069 |
| Mar 14, 2012 | Santa Ana, CA | Drugs | Voluntary Action Indicated (VAI) | 3003350069 |
| Feb 8, 2011 | Santa Ana, CA | Drugs | Voluntary Action Indicated (VAI) | 3003350069 |
| Jul 13, 2010 | Santa Ana, CA | Drugs | Voluntary Action Indicated (VAI) | 3003350069 |
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 3003350069 | Santa Ana, CA | 6 | Jan 17, 2025 |