FDA Inspection
Epien Medical, IncEpien Medical, Inc – FDA Inspection, Sep 29, 2009
Record Details
This FDA Inspection record concerns Epien Medical, Inc, with an inspection on September 29, 2009, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Epien Medical, Inc
- Inspection Date
- September 29, 2009
- Product Type
- Drugs
View Company Profile
ID · 44168e92-7f72-4355-8d1d-772344721090
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 616289
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
4- 21 CFR 211.100(b)Procedure Deviations Recorded and Justified
- 21 CFR 211.194(b)Test method modification records do not include
- 21 CFR 211.68(a)Written calibration / inspection records not kept
- 21 CFR 211.84(d)(2)Reports of Analysis (Components)
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 |
| December 11, 2013 | VAI | 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 859099 - 2013-12-11
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