Solevy Co., LLC

FDA Regulatory Profile

Solevy Co., LLC has 0 FDA recalls, 2 inspections, 2 510(k) clearances and 0 compliance actions on record.

Latest inspection
May 3, 2024 · VAI
Latest 510(k)
Apr 19, 2021

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Oct 23, 2026Not statedCurrent
510(k) clearances2Oct 4, 2026Not statedCurrent
Inspections2Oct 26, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
May 3, 2024Valencia, CADrugsVoluntary Action Indicated (VAI)3016842367
Feb 12, 2024Valencia, CADevicesVoluntary Action Indicated (VAI)3016842367

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.

Recent 510(k) Clearances

K-NumberDeviceDate
K203644Solevy Co. LLC Silicone Based Personal LubricantApr 19, 2021
K203654Solevy Co. LLC Water-Based Personal LubricantApr 19, 2021