EPIEN Medical, Inc.
FDA inspection history in St. Paul, Minnesota, 2018
- 1
- Form 483
Every document, by year
- Form 483
2018: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2018One Form 483, at St. Paul, Minnesota.
Cited most
Across all EPIEN Medical observations on file
- 21 CFR 211.84(d)(1)Testing and approval or rejection of components, drug product containers, and closures2
- 21 CFR 211.67(b)Equipment cleaning and maintenance1
The complete EPIEN Medical file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
St. Paul, Minnesota
One Form 483 · 2018 · 3 observations
Latest: Form 483, Dec 6, 2018 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2018-12-06 | 483 Form 483 | St. Paul, Minnesota | 3 | $99 |
Investigators on these documents
FEI number 3003428492 · most recent document Dec 6, 2018
About EPIEN Medical, Inc.
How many FDA Form 483s has EPIEN Medical, Inc. received?
FDA Intel has 1 Form 483 on file for EPIEN Medical, Inc.; the most recent is dated Dec 6, 2018.
When was EPIEN Medical, Inc. last inspected by FDA?
The most recent FDA inspection document on file for EPIEN Medical, Inc. is a Form 483 dated Dec 6, 2018, for the site in St. Paul, Minnesota.
What did FDA cite at EPIEN Medical, Inc.?
The regulations cited most in the observations on file for EPIEN Medical, Inc. are 21 CFR 211.84(d)(1) (Testing and approval or rejection of components, drug product containers, and closures), 2 times; 21 CFR 211.67(b) (Equipment cleaning and maintenance), 1 time.