Home / Companies / Azenta US Inc

Azenta US Inc

FDA Regulatory Profile

Azenta US Inc has 0 FDA recalls, 3 inspections, 0 510(k) clearances and 0 compliance actions on record.

Latest inspection
Sep 16, 2025 · NAI

Reviewing Azenta US Inc as a supplier? Request a free FDA snapshot: name up to five suppliers and get a PDF of their public FDA record, with sources and dates. You do not need an API connection. Each snapshot is prepared by hand.

Check this supplier

Or check Azenta US Inc yourself in Claude, Cursor or ChatGPT: get the full FDA risk summary, with inspections, warning letters, Form 483s and import alerts by site.

Get a free API key

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
Inspections3Nov 8, 2026Newest record Oct 28, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

Recent FDA Inspections

DateSiteProductClassificationFEI
Sep 16, 2025Plainfield, INBiologicsNo Action Indicated (NAI)3025562071
Jan 29, 2024Cleveland, OHBiologicsNo Action Indicated (NAI)3023907544
Oct 6, 2022Fresno, CABiologicsNo Action Indicated (NAI)3007495133

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 3025562071Plainfield, IN1Sep 16, 2025
FEI 3023907544Cleveland, OH1Jan 29, 2024
FEI 3007495133Fresno, CA1Oct 6, 2022

FDA data resources

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