Lauren R. Klein, MD, MS, Sponsor-Investigator
Form 483 issued April 23, 2019 · Minneapolis, Minnesota
- Inspection
- Apr 9 – Apr 23, 2019
- Investigator
- Sharon L. Matson
- Observations
- 8
- Pages
- 7
- FEI number
- 3015213291
In short: On April 23, 2019, FDA issued a Form 483 with 8 observations to Lauren R. Klein, MD, MS, Sponsor-Investigator in Minneapolis, Minnesota (FEI 3015213291) after an inspection that ran Apr 9 – Apr 23, 2019. The investigator was Sharon L. Matson. Most observations concern clinical (BIMO); the most-cited regulation is 21 CFR 312.62 (investigator recordkeeping and record retention).
At a glance
8 of 8 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
Not all changes in research activity were approved by an hlstitutional Review Board…
- 04
An investigation was not conducted in accordance…
This inspection in context
Sharon L. Matson
3 documents · 2018–2026
Cites 312.62(a) (investigator recordkeeping and record retention) more than any other section. Most of their documents are for sites in Minnesota.
The firmLauren R. Klein, MD, MS, Sponsor-Investigator history
All 2 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 Lauren R. Klein, MD, MS, Sponsor-Investigator?
FDA listed 8 observations on this Form 483, mostly about clinical (BIMO). The most-cited regulation is 21 CFR 312.62 (investigator recordkeeping and record retention). The opening words of each observation are shown on this page.
Who inspected Lauren R. Klein, MD, MS, Sponsor-Investigator?
Sharon L. Matson is named on this Form 483, for the inspection of Apr 9 – Apr 23, 2019. Each investigator has a profile showing what they cite most.
When was Lauren R. Klein, MD, MS, Sponsor-Investigator inspected by FDA?
The inspection ran Apr 9 – Apr 23, 2019, and the Form 483 is dated April 23, 2019.
How do I get the full Form 483 for Lauren R. Klein, MD, MS, Sponsor-Investigator?
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.