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Nextgen Biologics, Inc.

FDA Regulatory Profile

Nextgen Biologics, Inc. has 0 FDA recalls, 1 inspection, 2 510(k) clearances and 0 compliance actions on record.

Latest inspection
Sep 4, 2025 · NAI
Latest 510(k)
Oct 7, 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
Inspections1Oct 25, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
Sep 4, 2025Alachua, FLDevicesNo Action Indicated (NAI)3014820861

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
K210024NeoMatriX Wound MatrixOct 7, 2021
K181330NeoMatriX Wound MatrixOct 11, 2018

FDA data resources