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Kobayashi America Manufacturing, LLC

FDA Regulatory Profile

Kobayashi America Manufacturing, LLC has 0 FDA recalls, 3 inspections, 0 510(k) clearances and 1 compliance action on record.

Latest inspection
Mar 15, 2024 · 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
Inspections3Nov 8, 2026Newest record Oct 28, 2026Current
Compliance actions1Nov 2, 2026Newest record Oct 29, 2026Current

Recent FDA Inspections

DateSiteProductClassificationFEI
Mar 15, 2024Dalton, GADrugsVoluntary Action Indicated (VAI)3003079019
May 27, 2022Dalton, GADrugsOfficial Action Indicated (OAI)3003079019
Apr 28, 2022Dalton, GAFood/CosmeticsVoluntary Action Indicated (VAI)3003079019

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 3003079019Dalton, GA3Mar 15, 2024

FDA data resources

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