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Zentis North America, LLC

FDA Regulatory Profile

Zentis North America, LLC has 0 FDA recalls, 9 inspections, 0 510(k) clearances and 0 compliance actions on record.

Latest inspection
Jun 11, 2025 · NAI

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Nov 8, 2026File dated Nov 3, 2026Current
510(k) clearances0Nov 8, 2026File dated Nov 2, 2026Current
Inspections9Nov 11, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

Recent FDA Inspections

DateSiteProductClassificationFEI
Jun 11, 2025Plymouth, INFood/CosmeticsNo Action Indicated (NAI)3010158236
Jan 12, 2024Philadelphia, PAFood/CosmeticsNo Action Indicated (NAI)3003283288
Apr 9, 2018Philadelphia, PAFood/CosmeticsNo Action Indicated (NAI)3003283288
Jul 27, 2017Plymouth, INFood/CosmeticsNo Action Indicated (NAI)3010158236
Apr 11, 2013Philadelphia, PAFood/CosmeticsNo Action Indicated (NAI)3003283288
Sep 23, 2010Gardena, CAFood/CosmeticsNo Action Indicated (NAI)2017186
Mar 10, 2010Philadelphia, PAFood/CosmeticsVoluntary Action Indicated (VAI)3003283288
Oct 22, 2009Gardena, CAFood/CosmeticsNo Action Indicated (NAI)2017186
Jun 19, 2009Philadelphia, PAFood/CosmeticsVoluntary Action Indicated (VAI)3003283288

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 3010158236Plymouth, IN2Jun 11, 2025
FEI 3003283288Philadelphia, PA5Jan 12, 2024
FEI 2017186Gardena, CA2Sep 23, 2010

FDA data resources

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