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My DashboardInspection TrackerWarning LettersAvertix Medical, Inc.

All Warning Letters

Avertix Medical, Inc.

Warning LetterOpen

Avertix Medical, Inc., 40 Christopher Way, Ste 201 Eatontown , NJ 07724 United StatesIssued Sep 3, 2025Center for Devices and Radiological Health

Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy.

Violations15

Issue DateSep 3, 2025

Product TypeMedical Devices

StatusOpen

Letter Details

Firm: Avertix Medical, Inc.
Location: Avertix Medical, Inc., 40 Christopher Way, Ste 201 Eatontown , NJ 07724 United States
FEI Number: N/A
Country: United States
Issue Date: September 03, 2025
Issuing Office: Center for Devices and Radiological Health
Product Type: Medical Devices
Status: Open

Subject

CGMP/QSR/Medical Devices/Adulterated

Avertix Medical, Inc. FDA Warning Letter, September 3, 2025