FDA Intel

Hennepin County Med Ctr (Minneapolis) IRB #1

Form 483 issued August 23, 2018 · Minneapolis, Minnesota

Inspection
Aug 7 – Aug 23, 2018
Investigators
Kellie L. Thommes· Sharon L. Matson
Observations
4
Pages
4
FEI number
2127118

In short: On August 23, 2018, FDA issued a Form 483 with 4 observations to Hennepin County Med Ctr (Minneapolis) IRB #1 in Minneapolis, Minnesota (FEI 2127118) after an inspection that ran Aug 7 – Aug 23, 2018. The investigators were Kellie L. Thommes and Sharon L. Matson. Most observations concern clinical (BIMO); the most-cited regulation is 21 CFR 56.111 (criteria for IRB approval of research).

At a glance

4 of 4 observations on this 483 concern clinical (bimo).

Clinical (BIMO)4

What FDA observed

Preview: the opening words of each observation
  1. 01
    21 CFR 56.111(a)(4)21 CFR 5021 CFR 50.2321 CFR 50.24

    The IRB approved the conduct of research, but did not determine that informed consent would be…

  2. 02
    21 CFR 56.111(b)

    The IRB approved the conduct of research in a situation where some or all of the…

  3. 03
    21 CFR 56.110(b)

    The IRB used an expedited review procedure for research which did not appear in an FDA…

  4. 04
    21 CFR 56.108(a)(1)

    The IRB has no written procedure for conducting its initial and…

The full 483

Plus the full detail behind each one, exactly as FDA wrote it.

Get the full 483

This inspection in context

The investigator

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 firm

Hennepin County Med Ctr (Minneapolis) IRB #1 history

The site's inspection history, in date order.

Similar 483s

Other sites cited under 56.111(a)(4)

See how FDA wrote the same problem up elsewhere.

Questions about this 483

What did FDA find at Hennepin County Med Ctr (Minneapolis) IRB #1?

FDA listed 4 observations on this Form 483, mostly about clinical (BIMO). The most-cited regulation is 21 CFR 56.111 (criteria for IRB approval of research). The opening words of each observation are shown on this page.

Who inspected Hennepin County Med Ctr (Minneapolis) IRB #1?

Kellie L. Thommes and Sharon L. Matson are named on this Form 483, for the inspection of Aug 7 – Aug 23, 2018. Each investigator has a profile showing what they cite most.

When was Hennepin County Med Ctr (Minneapolis) IRB #1 inspected by FDA?

The inspection ran Aug 7 – Aug 23, 2018, and the Form 483 is dated August 23, 2018.

How do I get the full Form 483 for Hennepin County Med Ctr (Minneapolis) IRB #1?

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Hennepin County Med Ctr (Minneapolis) IRB #1 FDA 483 (Aug 2018) | FDA Intel