XGen Pharmaceuticals DJB, Inc.

FDA Regulatory Profile

XGen Pharmaceuticals DJB, Inc. has 0 FDA recalls, 7 inspections, 0 510(k) clearances and 0 compliance actions on record.

Latest inspection
Jun 14, 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
Inspections7Nov 8, 2026Newest record Oct 28, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

Recent FDA Inspections

DateSiteProductClassificationFEI
Jun 14, 2024Horseheads, NYDrugsVoluntary Action Indicated (VAI)3005548067
Aug 22, 2019Horseheads, NYDrugsVoluntary Action Indicated (VAI)3005548067
Jun 22, 2018Horseheads, NYDrugsVoluntary Action Indicated (VAI)3005548067
Feb 16, 2018Horseheads, NYDrugsVoluntary Action Indicated (VAI)3005548067
Dec 23, 2015Horseheads, NYDrugsVoluntary Action Indicated (VAI)3005548067
Mar 8, 2012Horseheads, NYDrugsVoluntary Action Indicated (VAI)3005548067
Jul 20, 2011Horseheads, NYDrugsNo Action Indicated (NAI)3005548067

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 3005548067Horseheads, NY7Jun 14, 2024

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