Company
United StatesO.N. Diagnostics, LLC, Berkeley, CA – FDA Inspections
Inspection records and compliance data for O.N. Diagnostics, LLC in Berkeley, California. 2 FDA inspections on record, 1 Form 483, last inspected March 17, 2026.
Company Profile
This profile covers O.N. Diagnostics, LLC based in Berkeley, California, United States.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 0
- NAI
- 1
- Unclassified
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected November 30, 2017. Last inspected March 17, 2026.
Most cited issue areas
- Corrective action procedures not documented1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| March 17, 2026 | Not classified | Medical Devices & Rad Health · Compliance: Medical Devices | 1307862 |
| November 30, 2017 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1034351 |
FDA documents
Form 483s (1)
People (2)
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Company Information
Name
O.N. Diagnostics, LLC
FEI Number
3010687441
Address
2150 Shattuck Ave Ste 610, Berkeley, California 94704, United States
Country
United States
ID: 15cd72c6-87bd-4541-b232-dd34f718779a