QUTEN RESEARCH INSTITIUTE LLC
FDA Regulatory Profile
QUTEN RESEARCH INSTITIUTE LLC has 1 FDA recall, 1 inspection, 0 510(k) clearances and 1 compliance action on record.
- Latest recall
- H-0418-2026 · Class II · Dec 16, 2025
- Latest inspection
- May 28, 2025 · NAI
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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 8, 2026 | File dated Nov 3, 2026 | Current |
| 510(k) clearances | 0 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
| Inspections | 1 | Nov 11, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 1 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
Recent Recalls
| Number | Class | Product | Date |
| H-0418-2026 | Class II | Qunol, Extra Strength Turmeric Capsule, 1000mg ,HDPE bottle with cap, BIO7771 120 count bottle… | Dec 16, 2025 |
Recent FDA Inspections
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 3016631136 | Pine Brook, NJ | 1 | May 28, 2025 |