Warning letterPosted March 17, 2026
FDA warning letter to Avertix Medical, Inc.
CGMP/QSR/Medical Devices/Adulterated
FDA posted a warning letter to Avertix Medical, Inc. on March 17, 2026; the letter is dated September 3, 2025. Subject: CGMP/QSR/Medical Devices/Adulterated. Issuing office: Center for Devices and Radiological Health.
On the record
- Company
- Avertix Medical, Inc.
- Subject
- CGMP/QSR/Medical Devices/Adulterated
- Issuing office
- Center for Devices and Radiological Health
- Letter dated
- 2025-09-03
- Posted by FDA
- 2026-03-17
- Source
- FDA warning letters ↗
CFR cited
The record cites 13 sections of 21 CFR Parts 803, 806 and 820.
The full record
An account shows the violations FDA described and each CFR section it cited.
What a warning letter is
A warning letter is FDA's notice to a company that it found significant violations of federal requirements. FDA asks for a written response, normally within 15 working days. The letter is advisory: it states the agency's position and is not a final agency action.
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