FDA Inspection
Epien Medical, IncEpien Medical, Inc – FDA Inspection, Dec 11, 2013
Record Details
This FDA Inspection record concerns Epien Medical, Inc, with an inspection on December 11, 2013, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Epien Medical, Inc
- Inspection Date
- December 11, 2013
- Product Type
- Drugs
View Company Profile
ID · 5d186172-82f0-445a-a3f9-d6c032284cec
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 859099
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
3- 21 CFR 211.84(d)(2)Reports of Analysis (Components)
- 21 CFR 211.84(d)(1)Identity Testing of Each Component
- 21 CFR 211.67(b)Written procedures not established/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 28, 2025 | VAI | Minneapolis District Office | Drug Quality Assurance |
| 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 |
| June 15, 2011 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Epien Medical, Inc
- FDA Inspection 1280917 - 2025-08-28
- FDA Inspection 1247073 - 2024-08-06
- FDA Inspection 1073560 - 2018-12-06
- FDA Inspection 1072268 - 2018-11-01
- FDA Inspection 730791 - 2011-06-15
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