Omega Biological Laboratories Inc.

FDA Regulatory Profile

Omega Biological Laboratories Inc. has 0 FDA recalls, 6 inspections, 0 510(k) clearances and 0 compliance actions on record.

Latest inspection
Jul 31, 2025 · VAI

Reviewing Omega Biological Laboratories 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 Omega Biological Laboratories 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
Inspections6Nov 10, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

Recent FDA Inspections

DateSiteProductClassificationFEI
Jul 31, 2025Lyndhurst, NJDrugsVoluntary Action Indicated (VAI)3002864704
Nov 7, 2018Lyndhurst, NJDrugsVoluntary Action Indicated (VAI)3002864704
Jun 25, 2014Lyndhurst, NJDrugsNo Action Indicated (NAI)3002864704
May 14, 2012Lyndhurst, NJDrugsVoluntary Action Indicated (VAI)3002864704
Jun 15, 2011Lyndhurst, NJDrugsVoluntary Action Indicated (VAI)3002864704
Jul 9, 2010Lyndhurst, NJDrugsVoluntary Action Indicated (VAI)3002864704

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 3002864704Lyndhurst, NJ6Jul 31, 2025

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