FDA Inspection
Guardian Medical USA Inc.Guardian Medical USA Inc. – FDA Inspection, Jun 2, 2026
Record Details
This FDA Inspection record concerns Guardian Medical USA Inc., with an inspection on June 2, 2026, issued by the Cincinnati District Office, covering medical devices & rad health.
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ID · a44c6b93-d379-4926-b794-ae36e87a1c2a
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1320072
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
6- ISO 13485:2016 Clause 4.1.2Risk-based approach not applied to QMS processes
- ISO 13485:2016 Clause 7.3.8Design and development transfer procedures not documented
- ISO 13485:2016 Clause 7.4.1Criteria for the evaluation and selection of suppliers not established
- ISO 13485:2016 Clause 7.5.6Planned results not consistently met during validation of processes
- ISO 13485:2016 Clause 8.3.1Procedure for nonconforming product not documented
- ISO 13485:2016 Clause 8.5.2Corrective action procedures not documented
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Guardian Medical USA Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| June 24, 2022 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Guardian Medical USA Inc.
- FDA Inspection 1174256 - 2022-06-24
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