Human Genome Sciences Inc

FDA Regulatory Profile

Human Genome Sciences Inc has 0 FDA recalls, 7 inspections, 0 510(k) clearances and 0 compliance actions on record.

Latest inspection
Jul 31, 2025 · 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 10, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

Recent FDA Inspections

DateSiteProductClassificationFEI
Jul 31, 2025Rockville, MDDrugsVoluntary Action Indicated (VAI)3003782237
Aug 30, 2018Rockville, MDDrugsNo Action Indicated (NAI)3003782237
Apr 11, 2016Rockville, MDDrugsVoluntary Action Indicated (VAI)3003782237
Nov 5, 2013Rockville, MDDrugsNo Action Indicated (NAI)3003782237
Nov 2, 2012Rockville, MDDrugsNo Action Indicated (NAI)3003782237
Sep 8, 2010Rockville, MDDrugsNo Action Indicated (NAI)3003782237
Jul 31, 2009Rockville, MDDrugsNo Action Indicated (NAI)3003782237

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 3003782237Rockville, MD7Jul 31, 2025

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