Burzynski Research Institute/ IRB
Form 483 issued October 28, 2010 · Houston, Texas
- Inspection
- Oct 12 – Oct 28, 2010
- Investigator
- Andrea A. Branche
- Observations
- 4
- Pages
- 2
- FEI number
- 1000220451
In short: On October 28, 2010, FDA issued a Form 483 with 4 observations to Burzynski Research Institute/ IRB in Houston, Texas (FEI 1000220451) after an inspection that ran Oct 12 – Oct 28, 2010. The investigator was Andrea A. Branche. 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).
What FDA observed
Preview: the opening words of each observation- 0121 CFR 56.108(a)(1)21 CFR 812.66
The IRB has no written procedure for conducting its initial…
- 02
The IRB has no written procedure for determining which projects require review…
- 03
Copies have not been maintained of all approved sample consent documents and progress…
- 0421 CFR 56.109(h)21 CFR 50
The IRB did not detennine at the time of initial review and at the time of…
This inspection in context
Andrea A. Branche
6 documents · 2009–2018
Cites 56.108(a)(1) (irb functions and operations) more than any other section. Most of their documents are for sites in Texas.
The firmBurzynski Research Institute/ IRB history
All 4 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 56.108(a)(1)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Burzynski Research Institute/ IRB?
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 Burzynski Research Institute/ IRB?
Andrea A. Branche is named on this Form 483, for the inspection of Oct 12 – Oct 28, 2010. Each investigator has a profile showing what they cite most.
When was Burzynski Research Institute/ IRB inspected by FDA?
The inspection ran Oct 12 – Oct 28, 2010, and the Form 483 is dated October 28, 2010.
How do I get the full Form 483 for Burzynski Research Institute/ IRB?
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.