Company
United StatesPublic company, NASDAQ: BBNXBeta Bionics, Inc (NASDAQ: BBNX), Irvine, CA – FDA Inspections
Inspection records and compliance data for Beta Bionics, Inc in Irvine, California. 2 FDA inspections on record, 1 Form 483, 2 warning letters, last inspected June 26, 2025. Publicly traded as NASDAQ: BBNX.
Company Profile
This profile covers Beta Bionics, Inc based in Irvine, California, United States.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 0
- NAI
- 0
- Unclassified
- 2
- Form 483s
- 1
- Warning letters
- 2
First inspected October 21, 2024. Last inspected June 26, 2025.
Most cited issue areas
- Design Validation - Risk analysis not performed/inadequate1 inspection
- Documentation1 inspection
- Individual Report of Malfunction1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| June 26, 2025 | Not classified | Medical Devices & Rad Health · Compliance: Medical Devices | 1273957 |
| October 21, 2024 | Not classified | Medical Devices & Rad Health | 1250089 |
FDA documents
Form 483s (1)
Warning Letters (2)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Beta Bionics, Inc
Stock ticker
BBNX
Exchange
NASDAQ
Share price
$16.51
Market cap
$897.6M
Price as of
November 13, 2026
FEI Number
3019004087
Address
11 Hughes, Irvine, California 92618, United States
Country
United States
ID: 275e80ad-2048-45cf-bfb7-8fd3d648b069