EPIEN Medical, Inc.
Form 483 issued December 6, 2018 · St. Paul, Minnesota
- Inspection
- Nov 26 – Dec 6, 2018
- Investigator
- James K. Ireland
- Observations
- 3
- Pages
- 3
- FEI number
- 3003428492
In short: On December 6, 2018, FDA issued a Form 483 with 3 observations to EPIEN Medical, Inc. in St. Paul, Minnesota (FEI 3003428492) after an inspection that ran Nov 26 – Dec 6, 2018. The investigator was James K. Ireland. Most observations concern materials and facilities & equipment; the most-cited regulation is 21 CFR 211.84 (testing and approval or rejection of components, drug product containers, and closures).
At a glance
2 of 3 observations on this 483 concern materials.
What FDA observed
Preview: the opening words of each observation- 01
Reports of analysis from component suppliers are accepted in lieu of testing each component for conformity…
- 02
Drug product component testing is deficient in that at least one specific test to verify the…
- 03
Written procedures are not established and followed for the cleaning and maintenance of equipment, including utensils…
This inspection in context
James K. Ireland
10 documents · 2016–2019
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Minnesota.
The firmEPIEN Medical, Inc. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.84(d)(2)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at EPIEN Medical, Inc.?
FDA listed 3 observations on this Form 483, mostly about materials and facilities & equipment. The most-cited regulation is 21 CFR 211.84 (testing and approval or rejection of components, drug product containers, and closures). The opening words of each observation are shown on this page.
Who inspected EPIEN Medical, Inc.?
James K. Ireland is named on this Form 483, for the inspection of Nov 26 – Dec 6, 2018. Each investigator has a profile showing what they cite most.
When was EPIEN Medical, Inc. inspected by FDA?
The inspection ran Nov 26 – Dec 6, 2018, and the Form 483 is dated December 6, 2018.
How do I get the full Form 483 for EPIEN Medical, Inc.?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.