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
RecordsCountLast refreshedSource as ofStatus
Recalls1Nov 8, 2026File dated Nov 3, 2026Current
510(k) clearances0Nov 8, 2026File dated Nov 2, 2026Current
Inspections1Nov 11, 2026Newest record Nov 5, 2026Current
Compliance actions1Nov 2, 2026Newest record Oct 29, 2026Current

Recent Recalls

NumberClassProductDate
H-0418-2026Class IIQunol, Extra Strength Turmeric Capsule, 1000mg ,HDPE bottle with cap, BIO7771 120 count bottle…Dec 16, 2025

Recent FDA Inspections

DateSiteProductClassificationFEI
May 28, 2025Pine Brook, NJFood/CosmeticsNo Action Indicated (NAI)3016631136

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

FacilityLocationInspectionsLatest
FEI 3016631136Pine Brook, NJ1May 28, 2025

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.