Lauren R. Klein, MD, MS, Sponsor-Investigator
FDA inspection history in Minneapolis, Minnesota, 2019 to 2021
- 1
- Warning letter
- 1
- Form 483
Every document, by year
- Warning letter
- Form 483
2019: one Form 483; 2021: one warning letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2019–21One Form 483 and one warning letter, at Minneapolis, Minnesota.
Cited most
Across all Lauren R. Klein, MD, MS, Sponsor-Investigator observations on file
- 21 CFR 312.62(a)Investigator recordkeeping and record retention2
- 21 CFR 312.20(a)Requirement for an IND1
- 21 CFR 312.50General responsibilities of sponsors1
- 21 CFR 312.57(a)Recordkeeping and record retention1
- 21 CFR 312.60General responsibilities of investigators1
The complete Lauren R. Klein, MD, MS, Sponsor-Investigator file.
All 2 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 and one Form 483 · 2019 to 2021 · 8 observations
Latest: Warning letter, May 6, 2021 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2021-05-06 | Warning letter Warning letter | Minneapolis, Minnesota | — | $99 |
| 2019-04-23 | 483 Form 483 | Minneapolis, Minnesota | 8 | $99 |
Investigators on these documents
FEI number 3015213291 · most recent document May 6, 2021
About Lauren R. Klein, MD, MS, Sponsor-Investigator
How many FDA Form 483s has Lauren R. Klein, MD, MS, Sponsor-Investigator received?
FDA Intel has 1 Form 483 on file for Lauren R. Klein, MD, MS, Sponsor-Investigator; the most recent is dated Apr 23, 2019.
When was Lauren R. Klein, MD, MS, Sponsor-Investigator last inspected by FDA?
The most recent FDA inspection document on file for Lauren R. Klein, MD, MS, Sponsor-Investigator is a Form 483 dated Apr 23, 2019, for the site in Minneapolis, Minnesota.
What did FDA cite at Lauren R. Klein, MD, MS, Sponsor-Investigator?
The regulations cited most in the observations on file for Lauren R. Klein, MD, MS, Sponsor-Investigator are 21 CFR 312.62(a) (Investigator recordkeeping and record retention), 2 times; 21 CFR 312.20(a) (Requirement for an IND), 1 time; 21 CFR 312.50 (General responsibilities of sponsors), 1 time.
Has Lauren R. Klein, MD, MS, Sponsor-Investigator received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Lauren R. Klein, MD, MS, Sponsor-Investigator; the most recent is dated May 6, 2021.