FDA Inspection
Cleveland Diagnostics, IncCleveland Diagnostics, Inc – FDA Inspection, Jul 20, 2026
Record Details
This FDA Inspection record concerns Cleveland Diagnostics, Inc, with an inspection on July 20, 2026, issued by the Center for Devices and Radiological Health, covering devices.
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ID · b5c83b51-fee9-48d1-9ab8-8790c839d8dc
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1327210
- Project area
- Postmarket Assurance: Devices
FDA Citations
5- ISO 13485:2016 Clause 7.1Records of risk management activities in product realization not maintained
- ISO 13485:2016 Clause 7.5.8Process for production and service provision not validated
- ISO 13485:2016 Clause 4.2.3Purchased product verification activities not established or implemented
- ISO 13485:2016 Clause 7.4.3Purchased product verification activities not established or implemented
- ISO 13485:2016 Clause 7.5.6Process for production and service provision not validated
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Other FDA inspections of Cleveland Diagnostics, Inc
1| Date | Classification | Office | Project area |
|---|---|---|---|
| February 15, 2022 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
Other documents for Cleveland Diagnostics, Inc
- FDA Inspection 1163486 - 2022-02-15
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