FDA Inspection
ENvue Medical (USA) IncENvue Medical (USA) Inc – FDA Inspection, Aug 29, 2025
Record Details
This FDA Inspection record concerns ENvue Medical (USA) Inc, with an inspection on August 29, 2025, issued by the Chicago District Office, covering medical devices & rad health.
- Company
- ENvue Medical (USA) Inc
- Inspection Date
- August 29, 2025
- Product Type
- Medical Devices & Rad Health
View Company Profile
ID · 5e69f9c8-7661-4bbe-901f-4a96716ae182
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1279929
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Medical Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.20(c)Management review - defined interval, sufficient frequency
- 21 CFR 820.22Quality Audits - defined intervals
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