Johns Hopkins, Bayview Medical Center, Human Subjects Committee
Form 483 issued September 7, 2001 · Baltimore, Maryland
- Inspection
- Jul 17 – Sep 7, 2001
- Investigator
- Diann Shaffer
- Observations
- 5
- Pages
- 2
- FEI number
- 1120913
In short: On September 7, 2001, FDA issued a Form 483 with 5 observations to Johns Hopkins, Bayview Medical Center, Human Subjects Committee in Baltimore, Maryland (FEI 1120913) after an inspection that ran Jul 17 – Sep 7, 2001. The investigator was Diann Shaffer. Most observations concern clinical (BIMO); the most-cited regulation is 21 CFR 56.115 (iRB records).
At a glance
5 of 5 observations on this 483 concern clinical (bimo).
Most cited: 21 CFR 56.115 (2×) · 56.108 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Observation 1: scanned text, readable in the full document.
- 02
Failure to prepare and maintain adequate documentation ofiRB minutes in sufficient detail to determine if an…
- 03
Failure to follow written procedures for conducting the initial review of research. IRB guideline "IV. A…
- 04
Failure to review research at fully convened IRB meetings at which a majority ofiRB members are…
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 56.115
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 5 observations on this Form 483, mostly about clinical (BIMO). The most-cited regulation is 21 CFR 56.115 (iRB records). 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 Jul 17 – 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 Jul 17 – 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.