Warning letterPosted February 24, 2026
FDA warning letter to Beta Bionics, Inc.
CGMP/QSR/Medical Devices/Adulterated
FDA posted a warning letter to Beta Bionics, Inc. on February 24, 2026; the letter is dated January 28, 2026. Subject: CGMP/QSR/Medical Devices/Adulterated. Issuing office: Center for Devices and Radiological Health.
On the record
- Company
- Beta Bionics, Inc.
- Subject
- CGMP/QSR/Medical Devices/Adulterated
- Issuing office
- Center for Devices and Radiological Health
- Letter dated
- 2026-01-28
- Posted by FDA
- 2026-02-24
- Source
- FDA warning letters ↗
CFR cited
The record cites 11 sections of 21 CFR Parts 7, 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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