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Berkeley Biologics LLC

FDA Regulatory Profile

Berkeley Biologics LLC has 0 FDA recalls, 5 inspections, 0 510(k) clearances and 1 compliance action on record.

Latest inspection
Sep 25, 2023 · OAI

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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
Inspections5Nov 8, 2026Newest record Oct 28, 2026Current
Compliance actions1Nov 2, 2026Newest record Oct 29, 2026Current

Recent FDA Inspections

DateSiteProductClassificationFEI
Sep 25, 2023Richmond, CABiologicsOfficial Action Indicated (OAI)1000100754
Jun 25, 2021Richmond, CABiologicsNo Action Indicated (NAI)1000100754
Aug 28, 2018Richmond, CABiologicsNo Action Indicated (NAI)1000100754
Mar 25, 2016Richmond, CABiologicsNo Action Indicated (NAI)1000100754
Feb 17, 2012Richmond, CABiologicsVoluntary Action Indicated (VAI)1000100754

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 1000100754Richmond, CA5Sep 25, 2023

FDA data resources

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