Handylee Enterprises (USA) Corp.

FDA Regulatory Profile

Handylee Enterprises (USA) Corp. has 0 FDA recalls, 6 inspections, 0 510(k) clearances and 1 compliance action on record.

Latest inspection
Feb 5, 2024 · NAI

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Nov 4, 2026 (checked Nov 8, 2026, unchanged)File dated Nov 3, 2026Current
510(k) clearances0Nov 8, 2026File dated Nov 2, 2026Current
Inspections6Nov 9, 2026Newest record Oct 28, 2026Current
Compliance actions1Nov 2, 2026Newest record Oct 29, 2026Current

Recent FDA Inspections

DateSiteProductClassificationFEI
Feb 5, 2024Maspeth, NYFood/CosmeticsNo Action Indicated (NAI)2000006568
Jan 11, 2024Maspeth, NYFood/CosmeticsVoluntary Action Indicated (VAI)2000006568
Aug 16, 2021Maspeth, NYFood/CosmeticsNo Action Indicated (NAI)2000006568
Jul 8, 2021Maspeth, NYFood/CosmeticsOfficial Action Indicated (OAI)2000006568
Jul 7, 2020Maspeth, NYFood/CosmeticsOfficial Action Indicated (OAI)2000006568
Aug 7, 2017Maspeth, NYFood/CosmeticsVoluntary Action Indicated (VAI)2000006568

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 2000006568Maspeth, NY6Feb 5, 2024

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