Warning letterPosted July 29, 2025
FDA warning letter to Onkos Surgical, Inc.
CGMP/QSR/Medical Devices/Adulterated
FDA posted a warning letter to Onkos Surgical, Inc. on July 29, 2025; the letter is dated July 21, 2025. Subject: CGMP/QSR/Medical Devices/Adulterated. Issuing office: Center for Devices and Radiological Health.
On the record
- Company
- Onkos Surgical, Inc.
- Subject
- CGMP/QSR/Medical Devices/Adulterated
- Issuing office
- Center for Devices and Radiological Health
- Letter dated
- 2025-07-21
- Posted by FDA
- 2025-07-29
- Source
- FDA warning letters ↗
CFR cited
The record cites 4 sections of 21 CFR Parts 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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