Hennepin County Med Ctr (Minneapolis) IRB #1
FDA inspection history in Minneapolis, 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 Minneapolis, Minnesota.
Cited most
Across all Hennepin County Med Ctr (Minneapolis) IRB #1 observations on file
- 21 CFR 56.111(a)(4)Criteria for IRB approval of research2
- 21 CFR 501
- 21 CFR 50.23Exception from general requirements1
- 21 CFR 50.24Exception from informed consent requirements for emergency research1
- 21 CFR 56.108(a)(1)IRB functions and operations1
The complete Hennepin County Med Ctr (Minneapolis) IRB #1 file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
Minneapolis, Minnesota
One Form 483 · 2018 · 4 observations
Latest: Form 483, Aug 23, 2018 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2018-08-23 | 483 Form 483 | Minneapolis, Minnesota | 4 | $99 |
Investigators on these documents
FEI number 2127118 · most recent document Aug 23, 2018
About Hennepin County Med Ctr (Minneapolis) IRB #1
How many FDA Form 483s has Hennepin County Med Ctr (Minneapolis) IRB #1 received?
FDA Intel has 1 Form 483 on file for Hennepin County Med Ctr (Minneapolis) IRB #1; the most recent is dated Aug 23, 2018.
When was Hennepin County Med Ctr (Minneapolis) IRB #1 last inspected by FDA?
The most recent FDA inspection document on file for Hennepin County Med Ctr (Minneapolis) IRB #1 is a Form 483 dated Aug 23, 2018, for the site in Minneapolis, Minnesota.
What did FDA cite at Hennepin County Med Ctr (Minneapolis) IRB #1?
The regulations cited most in the observations on file for Hennepin County Med Ctr (Minneapolis) IRB #1 are 21 CFR 56.111(a)(4) (Criteria for IRB approval of research), 2 times; 21 CFR 50, 1 time; 21 CFR 50.23 (Exception from general requirements), 1 time.