FDA Inspection
EVOLUTION DEVICES, INCEVOLUTION DEVICES, INC – FDA Inspection, Apr 15, 2026
Record Details
This FDA Inspection record concerns EVOLUTION DEVICES, INC, with an inspection on April 15, 2026, issued by the Center for Devices and Radiological Health, covering devices.
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ID · b09a8674-248b-4e79-9d34-2c920197904b
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1312460
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
10- ISO 13485:2016 Clause 8.5.2Corrective action not taken
- ISO 13485:2016 Clause 8.2.4Complaint handling procedures lack required elements
- ISO 13485:2016 Clause 7.5.8Procedures for monitoring and measuring equipment requirements not documented
- ISO 13485:2016 Clause 5.6.1Procedure for nonconforming product not documented
- ISO 13485:2016 Clause 7.4.1Procedures for purchasing process not documented
- ISO 13485:2016 Clause 8.2.4Internal audits not conducted to ensure QMS meets requirements and is effective
- ISO 13485:2016 Clause 7.1Product realization risk management processes not documented
- ISO 13485:2016 Clause 7.6Procedures for monitoring and measuring equipment requirements not documented
- ISO 13485:2016 Clause 8.2.2Complaint handling procedures lack required elements
- ISO 13485:2016 Clause 8.3.1Procedure for nonconforming product not documented
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