Company
United StatesBeacon Bio Dx LLC, Cleveland, OH – FDA Inspections
Inspection records and compliance data for Beacon Bio Dx LLC in Cleveland, Ohio. 5 FDA inspections on record (1 OAI), 3 Form 483s, last inspected September 01, 2026.
Company Profile
This profile covers Beacon Bio Dx LLC based in Cleveland, Ohio, United States.
FDA Inspection History
- FDA inspections
- 5
- OAI
- 1
- VAI
- 3
- NAI
- 1
- Form 483s
- 3
- Warning letters
- 0
First inspected June 1, 2011. Last inspected September 1, 2026.
Most cited issue areas
- Children as subjects1 inspection
- Design and development outputs not adequate1 inspection
- Design Validation - Risk analysis not performed/inadequate1 inspection
FDA inspections (5)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| September 1, 2026 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1333866 |
| July 28, 2023 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1210967 |
| July 7, 2017 | OAI | Medical Devices & Rad Health · Project Evaluation: Devices | 1017346 |
| February 5, 2015 | VAI | Medical Devices & Rad Health · Compliance: Devices | 912729 |
| June 1, 2011 | VAI | Medical Devices & Rad Health · Compliance: Devices | 725918 |
FDA documents
Form 483s (1)
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Company Information
Name
Beacon Bio Dx LLC
FEI Number
3000206198
Address
4415 Euclid Ave Ste 400, Cleveland, Ohio 44103, United States
Country
United States
ID: 87793c4f-a78d-48bb-a97a-cbe0b1afdf9f