Company
United StatesCleveland Diagnostics, Inc, Cleveland, OH – FDA Inspections
Inspection records and compliance data for Cleveland Diagnostics, Inc in Cleveland, Ohio. 2 FDA inspections on record, last inspected July 20, 2026.
Company Profile
This profile covers Cleveland Diagnostics, Inc based in Cleveland, Ohio, United States.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 0
- NAI
- 2
- Form 483s
- 0
- Warning letters
- 0
First inspected February 15, 2022. Last inspected July 20, 2026.
Most cited issue areas
- Process for production and service provision not validated1 inspection
- Purchased product verification activities not established or implemented1 inspection
- Records of risk management activities in product realization not maintained1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| July 20, 2026 | NAI | · Postmarket Assurance: Devices | 1327210 |
| February 15, 2022 | NAI | Medical Devices & Rad Health · Bioresearch Monitoring | 1163486 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Cleveland Diagnostics, Inc
FEI Number
3011015335
Address
3615 Superior Ave E Ste 4407b, Cleveland, Ohio 44114, United States
Country
United States
ID: e532f60c-5bf0-4692-9b5e-760188516e41