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Aphena Pharma Solutions - Tennessee LLC

FDA Regulatory Profile

Aphena Pharma Solutions - Tennessee LLC has 0 FDA recalls, 15 inspections, 0 510(k) clearances and 1 compliance action on record.

Latest inspection
Nov 3, 2025 · 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
Inspections15Nov 9, 2026Newest record Oct 28, 2026Current
Compliance actions1Nov 2, 2026Newest record Oct 29, 2026Current

Recent FDA Inspections

DateSiteProductClassificationFEI
Nov 3, 2025Cookeville, TNFood/CosmeticsNo Action Indicated (NAI)3003849479
Oct 30, 2024Cookeville, TNTobaccoNo Action Indicated (NAI)3003849479
Aug 30, 2023Cookeville, TNFood/CosmeticsNo Action Indicated (NAI)3003849479
Jul 25, 2022Cookeville, TNDrugsNo Action Indicated (NAI)3003849479
Jul 9, 2021Cookeville, TNDrugsNo Action Indicated (NAI)3003849479
Apr 17, 2019Cookeville, TNFood/CosmeticsNo Action Indicated (NAI)3003849479
Nov 16, 2017Cookeville, TNDrugsVoluntary Action Indicated (VAI)3003849479
Nov 30, 2016Cookeville, TNDrugsNo Action Indicated (NAI)3003849479
Jun 13, 2016Cookeville, TNDrugsVoluntary Action Indicated (VAI)3003849479
Feb 28, 2014Cookeville, TNFood/CosmeticsNo Action Indicated (NAI)3003849479
Dec 12, 2013Cookeville, TNDrugsVoluntary Action Indicated (VAI)3003849479
Oct 1, 2012Cookeville, TNFood/CosmeticsNo Action Indicated (NAI)3003849479
Aug 4, 2011Cookeville, TNDrugsNo Action Indicated (NAI)3003849479
Aug 20, 2010Cookeville, TNDrugsNo Action Indicated (NAI)3003849479
Feb 19, 2010Cookeville, TNFood/CosmeticsVoluntary Action Indicated (VAI)3003849479

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 3003849479Cookeville, TN15Nov 3, 2025

FDA data resources

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