Company
United StatesEpien Medical, Inc, White Bear Lake, MN – FDA Inspections
Inspection records and compliance data for Epien Medical, Inc in White Bear Lake, Minnesota. 7 FDA inspections on record, 2 Form 483s, last inspected August 28, 2025.
Company Profile
This profile covers Epien Medical, Inc based in White Bear Lake, Minnesota, United States.
FDA Inspection History
- FDA inspections
- 7
- OAI
- 0
- VAI
- 4
- NAI
- 3
- Form 483s
- 2
- Warning letters
- 0
First inspected September 29, 2009. Last inspected August 28, 2025.
Most cited issue areas
- Reports of Analysis (Components)3 inspections
- Written procedures not established/followed2 inspections
- Component identity verification1 inspection
FDA inspections (7)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| August 28, 2025 | VAI | Human Drugs · Drug Quality Assurance | 1280917 |
| August 6, 2024 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1247073 |
| December 6, 2018 | VAI | Human Drugs · Drug Quality Assurance | 1073560 |
| November 1, 2018 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1072268 |
| December 11, 2013 | VAI | Human Drugs · Drug Quality Assurance | 859099 |
| June 15, 2011 | NAI | Human Drugs · Drug Quality Assurance | 730791 |
| September 29, 2009 | VAI | Human Drugs · Drug Quality Assurance | 616289 |
FDA documents
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Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Epien Medical, Inc
FEI Number
3003428492
Address
4225 White Bear Pkwy Ste 600, White Bear Lake, Minnesota 55110, United States
Country
United States
ID: 448146b7-762c-4524-a71f-3308726efffd