Somalabs, Inc

FDA Regulatory Profile

Somalabs, Inc has 0 FDA recalls, 4 inspections, 0 510(k) clearances and 1 compliance action on record.

Latest inspection
Jul 8, 2021 · 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
Inspections4Nov 9, 2026Newest record Oct 28, 2026Current
Compliance actions1Nov 2, 2026Newest record Oct 29, 2026Current

Recent FDA Inspections

DateSiteProductClassificationFEI
Jul 8, 2021Northborough, MAFood/CosmeticsVoluntary Action Indicated (VAI)3009035868
Nov 6, 2019Northborough, MAFood/CosmeticsVoluntary Action Indicated (VAI)3009035868
Dec 12, 2018Northborough, MAFood/CosmeticsOfficial Action Indicated (OAI)3009035868
Dec 11, 2015Northborough, MAFood/CosmeticsVoluntary Action Indicated (VAI)3009035868

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 3009035868Northborough, MA4Jul 8, 2021

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