Human Biosciences, Inc.

FDA Regulatory Profile

Human Biosciences, Inc. has 0 FDA recalls, 5 inspections, 2 510(k) clearances and 1 compliance action on record.

Latest inspection
Feb 15, 2022 · VAI
Latest 510(k)
Dec 15, 2021

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Oct 23, 2026Not statedCurrent
510(k) clearances2Oct 4, 2026Not statedCurrent
Inspections5Oct 23, 2026Not statedCurrent
Compliance actions1Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
Feb 15, 2022Gaithersburg, MDDevicesVoluntary Action Indicated (VAI)3008770963
Jun 27, 2017Gaithersburg, MDDevicesNo Action Indicated (NAI)3008770963
Jul 19, 2013Gaithersburg, MDDevicesNo Action Indicated (NAI)3008770963
Jan 4, 2013Gaithersburg, MDDevicesVoluntary Action Indicated (VAI)3008770963
Oct 18, 2011Gaithersburg, MDDevicesOfficial Action Indicated (OAI)3008770963

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.

Recent 510(k) Clearances

K-NumberDeviceDate
K213092Cellusheet, CellufilDec 15, 2021
K122325SKINTEMP IIOct 26, 2012