Company
United StatesENvue Medical (USA) Inc, Arlington Heights, IL – FDA Inspections
Inspection records and compliance data for ENvue Medical (USA) Inc in Arlington Heights, Illinois. 1 FDA inspection on record, 1 Form 483, last inspected August 29, 2025.
Company Profile
This profile covers ENvue Medical (USA) Inc based in Arlington Heights, Illinois, United States.
FDA Inspection History
- FDA inspections
- 1
- OAI
- 0
- VAI
- 0
- NAI
- 1
- Form 483s
- 1
- Warning letters
- 0
Inspected August 29, 2025.
Most cited issue areas
- Management review - defined interval, sufficient frequency1 inspection
- Quality Audits - defined intervals1 inspection
FDA inspections (1)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| August 29, 2025 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Medical Devices | 1279929 |
FDA documents
Form 483s (1)
People (1)
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Company Information
Name
ENvue Medical (USA) Inc
FEI Number
3017081712
Address
762 W Algonquin Rd, Arlington Heights, Illinois 60005, United States
Country
United States
ID: b86539aa-dd9d-4cd8-86e1-37c0496e0105