Johns Hopkins, Bayview Medical Center, Human Subjects Committee
Form 483 issued September 7, 2001 · Baltimore, Maryland
- Inspection
- Sep 7, 2001
- Investigator
- Diann Shaffer
- Observations
- 4
- Pages
- 4
- FEI number
- 1119912
In short: On September 7, 2001, FDA issued a Form 483 with 4 observations to Johns Hopkins, Bayview Medical Center, Human Subjects Committee in Baltimore, Maryland (FEI 1119912) after an inspection that ran Sep 7, 2001. The investigator was Diann Shaffer. Most observations concern clinical (BIMO); the most-cited regulation is 21 CFR 56.108 (iRB functions and operations).
At a glance
4 of 4 observations on this 483 concern clinical (bimo).
Most cited: 21 CFR 56.108 (4×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Failure to follow written procedures for the initial review of research. IRB guideline "N. A. Full…
- 02
Two (2) IRB members questioned in writing about the IND status of hexamethonium; however, there was…
- 03
One (1) subcommittee member questioned in writing about the date the hexamethonium was manufactured. This member…
- 04
One (1) IRB member questioned in writing about the standard or usual dose of hexamethonium and…
This inspection in context
Diann Shaffer
2 documents · 2001
Cites 56.108 (irb functions and operations) more than any other section. Most of their documents are for sites in Maryland.
The firmJohns Hopkins, Bayview Medical Center, Human Subjects Committee history
The site's inspection history, in date order.
Similar 483sOther sites cited under 56.108
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Johns Hopkins, Bayview Medical Center, Human Subjects Committee?
FDA listed 4 observations on this Form 483, mostly about clinical (BIMO). The most-cited regulation is 21 CFR 56.108 (iRB functions and operations). The opening words of each observation are shown on this page.
Who inspected Johns Hopkins, Bayview Medical Center, Human Subjects Committee?
Diann Shaffer is named on this Form 483, for the inspection of Sep 7, 2001. Each investigator has a profile showing what they cite most.
When was Johns Hopkins, Bayview Medical Center, Human Subjects Committee inspected by FDA?
The inspection ran Sep 7, 2001, and the Form 483 is dated September 7, 2001.
How do I get the full Form 483 for Johns Hopkins, Bayview Medical Center, Human Subjects Committee?
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.