Threshold Enterprises Ltd

FDA Regulatory Profile

Threshold Enterprises Ltd has 8 FDA recalls, 9 inspections, 0 510(k) clearances and 1 compliance action on record.

Latest recall
F-0061-2020 · Class III · Sep 10, 2019
Latest inspection
May 22, 2026 · VAI

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls8Nov 4, 2026 (checked Nov 8, 2026, unchanged)File dated Nov 3, 2026Current
510(k) clearances0Nov 8, 2026File dated Nov 2, 2026Current
Inspections9Nov 9, 2026Newest record Oct 28, 2026Current
Compliance actions1Nov 2, 2026Newest record Oct 29, 2026Current

Recent Recalls

NumberClassProductDate
F-0061-2020Class IIISource Naturals Dietary Supplement Brain Charge Advanced Cognitive Support 30 tablets, 60…Sep 10, 2019
F-1097-2019Class IIPlanetary Herbals Mullein Lung Complex; 1000 mg; 15 count, item number PF0003; 90 count - Item…Dec 7, 2018
F-3338-2017Class IIPlanetary Herbals Ginseng Classic; Classic Chinese Energizer 710 mg; 60 and 120 UPC 0 21078 10215…Jun 16, 2017
F-2178-2017Class IISource Naturals Dietary Supplement Vitamin D-3; Bioactive Form for Bone and Immune Health 2000…Dec 12, 2016
F-2383-2017Class IISource Naturals Renewal Antioxidant Tablet: 10 Count Sample Pack, 30 Count, 60 Count, & 120 Count…Sep 11, 2015
F-2380-2017Class IISource Naturals Hydrogen Boost Capsule: 6 Count Trial, 30 Count, 60 Count; Ingredient…Sep 11, 2015
F-1100-2014Class IISource Naturals Essential Enzyme Ultra VEGI-CAP: Premium Digestive Enzyme Blend; 30, 60, 90 & 120…Nov 22, 2013
F-0100-2014Class IISerene Science/Source Naturals brand GABA (Gamma-Aminobutyric Acid), CALM MIND, A dietary…Sep 20, 2013

Recent FDA Inspections

DateSiteProductClassificationFEI
May 22, 2026Scotts Valley, CAFood/CosmeticsVoluntary Action Indicated (VAI)2918667
Sep 10, 2025Santa Cruz, CAFood/CosmeticsNo Action Indicated (NAI)3013942638
Aug 29, 2025Winchester, VAFood/CosmeticsNo Action Indicated (NAI)3011402303
Aug 23, 2024Winchester, VAFood/CosmeticsNo Action Indicated (NAI)3011402303
Aug 27, 2018Scotts Valley, CAFood/CosmeticsVoluntary Action Indicated (VAI)2918667
Apr 25, 2017Scotts Valley, CAFood/CosmeticsOfficial Action Indicated (OAI)2918667
Apr 20, 2016Scotts Valley, CAFood/CosmeticsOfficial Action Indicated (OAI)2918667
Sep 3, 2013Scotts Valley, CAFood/CosmeticsVoluntary Action Indicated (VAI)2918667
Jul 14, 2011Scotts Valley, CAFood/CosmeticsNo Action Indicated (NAI)2918667

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 2918667Scotts Valley, CA6May 22, 2026
FEI 3013942638Santa Cruz, CA1Sep 10, 2025
FEI 3011402303Winchester, VA2Aug 29, 2025

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