Hennepin Healthcare System, Inc.
FDA inspection history in Minneapolis, Minnesota, 2019 to 2021
- 1
- Warning letter
- 1
- Response
- 1
- Form 483
Every document, by year
- Warning letter
- Response
- Form 483
2019: one 483 response and one Form 483; 2021: one warning letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2019–21One 483 response, one Form 483 and one warning letter, at Minneapolis, Minnesota.
Cited most
Across all Hennepin Healthcare System observations on file
- 21 CFR 312.20(a)Requirement for an IND1
- 21 CFR 312.50General responsibilities of sponsors1
- 21 CFR 312.60General responsibilities of investigators1
- 21 CFR 312.62(a)Investigator recordkeeping and record retention1
- 21 CFR 312.66Assurance of IRB review1
The complete Hennepin Healthcare System file.
All 3 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Minneapolis, Minnesota
One warning letter, one 483 response and one Form 483 · 2019 to 2021 · 6 observations
Latest: Warning letter, May 5, 2021 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2021-05-05 | Warning letter Warning letter | Minneapolis, Minnesota | — | $99 |
| 2019-05-17 | Response 483 response | Minneapolis, Minnesota | — | $199 |
| 2019-04-26 | 483 Form 483 | Minneapolis, Minnesota | 6 | $99 |
Investigators on these documents
FEI number 3015212514 · most recent document May 5, 2021
About Hennepin Healthcare System, Inc.
How many FDA Form 483s has Hennepin Healthcare System, Inc. received?
FDA Intel has 1 Form 483 on file for Hennepin Healthcare System, Inc.; the most recent is dated Apr 26, 2019.
When was Hennepin Healthcare System, Inc. last inspected by FDA?
The most recent FDA inspection document on file for Hennepin Healthcare System, Inc. is a Form 483 dated Apr 26, 2019, for the site in Minneapolis, Minnesota.
What did FDA cite at Hennepin Healthcare System, Inc.?
The regulations cited most in the observations on file for Hennepin Healthcare System, Inc. are 21 CFR 312.20(a) (Requirement for an IND), 1 time; 21 CFR 312.50 (General responsibilities of sponsors), 1 time; 21 CFR 312.60 (General responsibilities of investigators), 1 time.
Has Hennepin Healthcare System, Inc. received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Hennepin Healthcare System, Inc.; the most recent is dated May 5, 2021.