Hennepin Healthcare System, Inc.
Form 483 issued April 26, 2019 · Minneapolis, Minnesota
- Inspection
- Apr 10 – Apr 26, 2019
- Investigator
- Kellie L. Thommes
- Observations
- 6
- Pages
- 6
- FEI number
- 3015212514
In short: On April 26, 2019, FDA issued a Form 483 with 6 observations to Hennepin Healthcare System, Inc. in Minneapolis, Minnesota (FEI 3015212514) after an inspection that ran Apr 10 – Apr 26, 2019. The investigator was Kellie L. Thommes. Most observations concern clinical (BIMO).
At a glance
6 of 6 observations on this 483 concern clinical (bimo).
What FDA observed
Preview: the opening words of each observation- 01
The sponsor failed to submit an IND to the FDA prior to conducting a clinical investigation…
- 02
Legally effective informed consent was not obtained from a subject or the subject's legally authorized representative…
- 03
An investigation was not conducted in accordance…
- 04
Failure to ensure proper…
This inspection in context
Kellie L. Thommes
4 documents · 2018–2025
Cites 50.23 (exception from general requirements) more than any other section. Most of their documents are for sites in Minnesota.
The firmHennepin Healthcare System, Inc. history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 312.20(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Hennepin Healthcare System, Inc.?
FDA listed 6 observations on this Form 483, mostly about clinical (BIMO). The opening words of each observation are shown on this page.
Who inspected Hennepin Healthcare System, Inc.?
Kellie L. Thommes is named on this Form 483, for the inspection of Apr 10 – Apr 26, 2019. Each investigator has a profile showing what they cite most.
When was Hennepin Healthcare System, Inc. inspected by FDA?
The inspection ran Apr 10 – Apr 26, 2019, and the Form 483 is dated April 26, 2019.
How do I get the full Form 483 for Hennepin Healthcare System, 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.