Prime Enterprises LLC

FDA Regulatory Profile

Prime Enterprises LLC has 0 FDA recalls, 7 inspections, 0 510(k) clearances and 2 compliance actions on record.

Latest inspection
Jul 13, 2026 · VAI

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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
Inspections7Nov 8, 2026Newest record Oct 28, 2026Current
Compliance actions2Nov 2, 2026Newest record Oct 29, 2026Current

Recent FDA Inspections

DateSiteProductClassificationFEI
Jul 13, 2026Hialeah, FLDrugsVoluntary Action Indicated (VAI)1036626
Aug 13, 2025Hialeah, FLFood/CosmeticsNo Action Indicated (NAI)1036626
Sep 1, 2023Hialeah, FLVeterinaryVoluntary Action Indicated (VAI)1036626
Jun 13, 2018Hialeah, FLDrugsNo Action Indicated (NAI)1036626
Jun 8, 2015Hialeah, FLDrugsVoluntary Action Indicated (VAI)1036626
Jan 3, 2013Hialeah, FLFood/CosmeticsVoluntary Action Indicated (VAI)1036626
Jul 13, 2009Hialeah, FLDrugsVoluntary Action Indicated (VAI)1036626

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 1036626Hialeah, FL7Jul 13, 2026

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