FDA Inspection
Epien Medical, IncEpien Medical, Inc – FDA Inspection, Aug 28, 2025
Record Details
This FDA Inspection record concerns Epien Medical, Inc, with an inspection on August 28, 2025, issued by the Minneapolis District Office, covering human drugs.
View Company Profile
ID · 453bd0ae-ddc7-4c12-ba8c-9f53f2165115
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1280917
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
5- 21 CFR 211.56(a)Sanitation--buildings not clean, free of infestation
- 21 CFR 211.25(c)Inadequate number of personnel
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.166(a)Written program not followed
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Epien Medical, Inc
6| Date | Classification | Office | Project area |
|---|---|---|---|
| August 6, 2024 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| December 6, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| November 1, 2018 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| December 11, 2013 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 15, 2011 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Epien Medical, Inc
- FDA Inspection 1247073 - 2024-08-06
- FDA Inspection 1073560 - 2018-12-06
- FDA Inspection 1072268 - 2018-11-01
- FDA Inspection 859099 - 2013-12-11
- FDA Inspection 730791 - 2011-06-15
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.