Device establishmentActive, RegisteredFDA warning letter on file
AVERTIX MEDICAL INC.
AVERTIX MEDICAL INC. is an FDA-registered device establishment (FEI 3017374019) located in Eatontown, New Jersey. The facility is active, registered. Its most recent FDA inspection on record (2025-03-11) was classified OAI. FDA has issued 1 warning letter(s) to this facility.
FDA warning letter
A warning letter is FDA's formal notice of significant violations that require prompt correction. It can hold up product approvals, trigger import alerts, and put supply agreements at risk until the issues are resolved and FDA closes it out.
Establishment record
Inspection history
Mar 28, 2022 · Voluntary Action Indicated (VAI)
Mar 28, 2022 · No Action Indicated (NAI)
FDA record timeline
Combined chronology of the public records shown on this page. FDA coverage varies by dataset and year.
Questions
Is AVERTIX MEDICAL INC. registered with the FDA?
Yes. AVERTIX MEDICAL INC. is an FDA-registered device establishment (FEI 3017374019) in Eatontown, New Jersey. Its current registration status is Active, Registered.
Has AVERTIX MEDICAL INC. received an FDA warning letter?
Yes. FDA issued a warning letter to AVERTIX MEDICAL INC.; the most recent is dated Sep 3, 2025 (CGMP/QSR/Medical Devices/Adulterated).
What does AVERTIX MEDICAL INC. do?
AVERTIX MEDICAL INC.'s FDA-registered operations are: Unknown, Develop Specifications But Do Not Manufacture At This Facility, Complaint File Establishment per 21 CFR 820.198.
Related facilities
Source: FDA public data · status as of 2026-08-22