Company
United StatesEnterra Medical, Inc., Minneapolis, MN – FDA Inspections
Inspection records and compliance data for Enterra Medical, Inc. in Minneapolis, MN. 1 FDA inspection on record, 1 Form 483, last inspected May 04, 2026.
Company Profile
This profile covers Enterra Medical, Inc. based in Minneapolis, MN, United States.
FDA Inspection History
- FDA inspections
- 1
- OAI
- 0
- VAI
- 0
- NAI
- 0
- Unclassified
- 1
- Form 483s
- 1
- Warning letters
- 0
Inspected May 4, 2026.
Most cited issue areas
- Criteria for the evaluation and selection of suppliers not established1 inspection
- Process for production and service provision not validated1 inspection
- Product realization risk management processes not documented1 inspection
FDA inspections (1)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| May 4, 2026 | Not classified | Medical Devices & Rad Health · Project Evaluation: Devices | 1315766 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Enterra Medical, Inc.
FEI Number
3027386225
Address
5353 Wayzata Blvd Ste 400, Minneapolis, MN 55416-1333, United States
Country
United States
ID: 6b8b47b0-0b59-4192-bb09-da8ae0d77fbf