Company
United StatesESI Inc., Minneapolis, MN – FDA Inspections
Inspection records and compliance data for ESI Inc. in Minneapolis, Minnesota. 4 FDA inspections on record, 1 Form 483, last inspected March 26, 2026.
Company Profile
This profile covers ESI Inc. based in Minneapolis, Minnesota, United States.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 0
- VAI
- 0
- NAI
- 3
- Unclassified
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected July 6, 2012. Last inspected March 26, 2026.
Most cited issue areas
- Complaint handling procedures lack required elements1 inspection
- Design and development procedures not documented1 inspection
- Impact of changes to purchased product not determined1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| March 26, 2026 | Not classified | Medical Devices & Rad Health · Compliance: Medical Devices | 1310166 |
| May 17, 2019 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1096338 |
| August 11, 2015 | NAI | Medical Devices & Rad Health · Compliance: Devices | 938169 |
| July 6, 2012 | NAI | Medical Devices & Rad Health · Compliance: Devices | 789659 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
ESI Inc.
FEI Number
3004181533
Address
2915 Everest Ln N, Minneapolis, Minnesota 55447, United States
Country
United States
ID: 9f4aa9cf-a51c-4a89-9044-39df332d0c09